Caribbean Dermatology Symposium

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

Clinicians have an expanding range of options to offer patients with persistent hyperhidrosis, Dr. David M. Pariser said at the Caribbean Dermatology Symposium.

Hyperhidrosis currently affects an estimated 7.8 million individuals in the United States. About half have axillary hyperhidrosis, and include about 1.3 million people who report hyperhidrosis that is “barely tolerable” or “intolerable,” Dr. Pariser said at the meeting, provided by Global Academy for Medical Education.

The treatment options include next generation antiperspirants that contain aluminum zirconium trichlorohydrex, which he said are more effective and less irritating than previously available products.

Although many patients apply antiperspirant as part of their morning routines, topical antiperspirants with aluminum chloride are effective when applied overnight, or for at least 6-8 hours, according to Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, Va. To avoid irritating acid formation, patients should make sure the skin is dry before application, but if irritation occurs, he recommends that it should be washed off in the morning “before sweating begins.”

Aluminum chloride products should be applied nightly until patients see improvement, and then they can decrease the frequency of use. Concerns about a potential link between aluminum and Alzheimer’s disease stem from a 1960s study that was never successfully replicated, he pointed out.

In general, topical agents are a useful adjunct to other hyperhidrosis treatments, such as onabotulinumtoxinA, Dr. Pariser said. “Many insurance companies consider treatment of hyperhidrosis with iontophoresis or botulinum toxin medically necessary when topical aluminum chloride or other extra strength antiperspirants are ineffective or result in irritation,” he noted.

Other new topical products on the horizon for hyperhidrosis include glycopyrrolate wipes and gel, oxybutynin gel, and topical botulinum toxins, he added.

Patients suffering from generalized hyperhidrosis or hyperhidrosis of a spinal cord injury may benefit from systemic treatment, although no systemic agents are currently approved by the Food and Drug Administration for this purpose, Dr. Pariser said.

Glycopyrrolate is the preferred systemic medication for off-label hyperhidrosis treatment, and patients typically start at 1 mg twice daily, increasing the dose by 1 mg a day each week until they achieve the desired improvement or are unable to tolerate adverse effects, he said. Data also support the use of oral oxybutynin for hyperhidrosis, he noted.

Patients seeking more “permanent” treatment for hyperhidrosis might consider microwave thermolysis with an FDA-cleared device designed to stop sweating by using microwaves to destroy the eccrine glands, which do not regenerate, Dr. Pariser said. The device works by delivering microwave energy precisely in the dermal-fat interface region. Deeper tissue is unaffected, and contact cooling protects the epidermis and upper dermis.

Side effects from microwave thermolysis are usually minimal and transient, he noted. “The most common side effects are swelling and tenderness in the treated area, which can last up to a few weeks.”

By contrast, the effects of botulinum toxin on hyperhidrosis are not permanent, but patients report a high level of satisfaction and improved quality of life with this treatment option, he said. Duration of treatment varies, but data from a 16-month, randomized, double-blind trial of 207 patients showed a mean duration of 7 months between treatments.

Overall, treatment of patients with focal hyperhidrosis “leads to greater improvement of a patient’s quality of life than treatment of any other dermatologic disorder,” Dr. Pariser said. Treatments are relatively easy to learn, economically viable, and easily incorporated into a routine office practice, he said.

Dr. Pariser disclosed ties with Allergan, Dermira, Watson Labs, Ulthera, Brickell Biotech, Revance, Anterios, and Theravida.

Global Academy and this news organization are owned by the same parent company.

The Food and Drug Administration wants to become more transparent and informative in its drug regulatory decision making, Dr. Jonathan Wilkin said at the Caribbean Dermatology Symposium.

“Part of this approach is the structured benefit-risk assessment tool,” he said in an interview.

The Prescription Drug User Fee Act (PDUFA) is reauthorized every 5 years, most recently in 2013, Dr. Wilkin said at the meeting, provided by Global Academy for Medical Education.

Two notable changes to PDUFA V (the fifth authorization of PDUFA) from previous versions are a focus on getting input from patients and their families on what constitutes a clinically meaningful improvement, and the publication of the FDA’s draft document on Structured Benefit-Risk Assessment, which is written for FDA staff and regulated drug manufacturers, explained Dr. Wilkin, a dermatologist in the Cayman Islands.

These changes are playing out with specific steps to increase patient participation and informing into the FDA’s decision-making process, said Dr. Wilkin, a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products.

“Patients, their families, and patient advocacy groups are being invited to attend meetings with FDA to discuss patient needs in specific diseases, such as psoriasis and alopecia areata. This is expected to lead to perspectives on the benefit-risk assessments by the patients, for example, what risks they are willing to accept for what level of direct benefit, and their relationship to patient-reported outcome measures in clinical trials,” he said. “In the future, these patient reported outcome measures may be in package inserts and could be useful in physicians' discussions of therapeutic options with patients.”

The FDA’s guidance documents are designed to represent the current thinking of the FDA on a particular topic, said Dr. Wilkin. The guidance documents are written to be generally applicable, and are not binding. “Other approaches may be used as long as they comply with governing statutes and regulations,” he said at the meeting.

In addition, it may even be possible that under some circumstances FDA guidance documents may be deemed inappropriate, and the FDA reserves the right to adopt a different approach if the circumstances require it, he added.

Clinicians need not stay on the sidelines when it comes to guidance documents, said Dr. Wilkin, who highlighted several ways dermatologists can get involved in the process:

• Offer input on works in progress: Clinicians can provide input on FDA guidance documents under development.

• Propose something new: Clinicians can make a case for why a guidance document is needed in a particular area.

• Draft your own: Clinicians can even submit drafts of their proposed guidance documents for consideration by the FDA. To submit a draft for the FDA’s consideration, mark the document “Guidance Document Submission,” and send it to: Division of Dockets Management (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD, 20852.

• Suggest a revision: Clinicians can, at any time, suggest that the FDA revise or withdraw an already existing guidance document. The suggestion should address why the revision or withdrawal is needed, and how it should be revised, if applicable.

• Leave a comment: Once a year, the FDA publishes a list of potential topics for guidance document development or revision in the next year. The list is published in the Federal Register and online. Clinicians can comment on the list by proposing alternative topics or making recommendations related to the topics being considered.

“To participate in the development and issuance of guidance documents through one of the mechanisms described, contact the center or office that is responsible for the regulatory activity covered by the guidance document,” Dr. Wilkin said.

Global Academy and this news organization are owned by the same parent company. Dr. Wilkin had no relevant financial conflicts to disclose.

This article was updated 3/21/16.

The Food and Drug Administration wants to become more transparent and informative in its drug regulatory decision making, Dr. Jonathan Wilkin said at the Caribbean Dermatology Symposium.

“Part of this approach is the structured benefit-risk assessment tool,” he said in an interview.

The Prescription Drug User Fee Act (PDUFA) is reauthorized every 5 years, most recently in 2013, Dr. Wilkin said at the meeting, provided by Global Academy for Medical Education.

Two notable changes to PDUFA V (the fifth authorization of PDUFA) from previous versions are a focus on getting input from patients and their families on what constitutes a clinically meaningful improvement, and the publication of the FDA’s draft document on Structured Benefit-Risk Assessment, which is written for FDA staff and regulated drug manufacturers, explained Dr. Wilkin, a dermatologist in the Cayman Islands.

These changes are playing out with specific steps to increase patient participation and informing into the FDA’s decision-making process, said Dr. Wilkin, a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products.

“Patients, their families, and patient advocacy groups are being invited to attend meetings with FDA to discuss patient needs in specific diseases, such as psoriasis and alopecia areata. This is expected to lead to perspectives on the benefit-risk assessments by the patients, for example, what risks they are willing to accept for what level of direct benefit, and their relationship to patient-reported outcome measures in clinical trials,” he said. “In the future, these patient reported outcome measures may be in package inserts and could be useful in physicians' discussions of therapeutic options with patients.”

The FDA’s guidance documents are designed to represent the current thinking of the FDA on a particular topic, said Dr. Wilkin. The guidance documents are written to be generally applicable, and are not binding. “Other approaches may be used as long as they comply with governing statutes and regulations,” he said at the meeting.

In addition, it may even be possible that under some circumstances FDA guidance documents may be deemed inappropriate, and the FDA reserves the right to adopt a different approach if the circumstances require it, he added.

Clinicians need not stay on the sidelines when it comes to guidance documents, said Dr. Wilkin, who highlighted several ways dermatologists can get involved in the process:

• Offer input on works in progress: Clinicians can provide input on FDA guidance documents under development.

• Propose something new: Clinicians can make a case for why a guidance document is needed in a particular area.

• Draft your own: Clinicians can even submit drafts of their proposed guidance documents for consideration by the FDA. To submit a draft for the FDA’s consideration, mark the document “Guidance Document Submission,” and send it to: Division of Dockets Management (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD, 20852.

• Suggest a revision: Clinicians can, at any time, suggest that the FDA revise or withdraw an already existing guidance document. The suggestion should address why the revision or withdrawal is needed, and how it should be revised, if applicable.

• Leave a comment: Once a year, the FDA publishes a list of potential topics for guidance document development or revision in the next year. The list is published in the Federal Register and online. Clinicians can comment on the list by proposing alternative topics or making recommendations related to the topics being considered.

“To participate in the development and issuance of guidance documents through one of the mechanisms described, contact the center or office that is responsible for the regulatory activity covered by the guidance document,” Dr. Wilkin said.

Global Academy and this news organization are owned by the same parent company. Dr. Wilkin had no relevant financial conflicts to disclose.

This article was updated 3/21/16.

The Food and Drug Administration wants to become more transparent and informative in its drug regulatory decision making, Dr. Jonathan Wilkin said at the Caribbean Dermatology Symposium.

“Part of this approach is the structured benefit-risk assessment tool,” he said in an interview.

The Prescription Drug User Fee Act (PDUFA) is reauthorized every 5 years, most recently in 2013, Dr. Wilkin said at the meeting, provided by Global Academy for Medical Education.

Two notable changes to PDUFA V (the fifth authorization of PDUFA) from previous versions are a focus on getting input from patients and their families on what constitutes a clinically meaningful improvement, and the publication of the FDA’s draft document on Structured Benefit-Risk Assessment, which is written for FDA staff and regulated drug manufacturers, explained Dr. Wilkin, a dermatologist in the Cayman Islands.

These changes are playing out with specific steps to increase patient participation and informing into the FDA’s decision-making process, said Dr. Wilkin, a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products.

“Patients, their families, and patient advocacy groups are being invited to attend meetings with FDA to discuss patient needs in specific diseases, such as psoriasis and alopecia areata. This is expected to lead to perspectives on the benefit-risk assessments by the patients, for example, what risks they are willing to accept for what level of direct benefit, and their relationship to patient-reported outcome measures in clinical trials,” he said. “In the future, these patient reported outcome measures may be in package inserts and could be useful in physicians' discussions of therapeutic options with patients.”

The FDA’s guidance documents are designed to represent the current thinking of the FDA on a particular topic, said Dr. Wilkin. The guidance documents are written to be generally applicable, and are not binding. “Other approaches may be used as long as they comply with governing statutes and regulations,” he said at the meeting.

In addition, it may even be possible that under some circumstances FDA guidance documents may be deemed inappropriate, and the FDA reserves the right to adopt a different approach if the circumstances require it, he added.

Clinicians need not stay on the sidelines when it comes to guidance documents, said Dr. Wilkin, who highlighted several ways dermatologists can get involved in the process:

• Offer input on works in progress: Clinicians can provide input on FDA guidance documents under development.

• Propose something new: Clinicians can make a case for why a guidance document is needed in a particular area.

• Draft your own: Clinicians can even submit drafts of their proposed guidance documents for consideration by the FDA. To submit a draft for the FDA’s consideration, mark the document “Guidance Document Submission,” and send it to: Division of Dockets Management (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD, 20852.

• Suggest a revision: Clinicians can, at any time, suggest that the FDA revise or withdraw an already existing guidance document. The suggestion should address why the revision or withdrawal is needed, and how it should be revised, if applicable.

• Leave a comment: Once a year, the FDA publishes a list of potential topics for guidance document development or revision in the next year. The list is published in the Federal Register and online. Clinicians can comment on the list by proposing alternative topics or making recommendations related to the topics being considered.

“To participate in the development and issuance of guidance documents through one of the mechanisms described, contact the center or office that is responsible for the regulatory activity covered by the guidance document,” Dr. Wilkin said.

Global Academy and this news organization are owned by the same parent company. Dr. Wilkin had no relevant financial conflicts to disclose.

This article was updated 3/21/16.

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – Emerging data increasingly link psoriasis with cardiovascular disease, diabetes, and depression, leading one expert to suggest a more integrated approach to care in patients with these comorbid conditions.

“I think people are starting to understand that the skin is just a marker for inflammation,” Dr. J. Mark Jackson of the University of Louisville (Ky.), said at this year’s annual Caribbean Dermatology Symposium, provided by Global Academy for Medical Education, a sister company to this news organization.

Growing evidence suggests cardiovascular disease is more common in patients with severe psoriasis. The overlap between the two disease states is thought to occur through similar patterns of inflammation, which Dr. Jackson said indicates that patient outcomes for both could be better if clinicians take an integrated approach to treatment. “Skin disease is an excellent way to study new therapies for other diseases,” said Dr. Jackson. “We can actually look at the skin, so it’s a lot easier to study it than the kidney, heart, or lung” (J Am Acad Dermatol. 2012 Nov 12;67[3]:357-62).

Screening for CVD, as well as for other comorbidities, such as diabetes and depression – both of which tend to occur at higher rates in persons with psoriasis – could also help improve compliance rates, according to Dr. Jackson (Dermatology. 2012;225[2]:121-6). .

“Especially if patients are heavy, if they smoke, if their lipids are high, if they have high blood pressure, or a history of heart disease, it’s important to remember that all of these things are connected to chronic inflammation. I think if we keep that in mind, we can have a better health outcome overall,” Dr. Jackson said.

A survey of 163 psoriasis patients published in 2012 found that comorbidities significantly affected patients’ preferences for psoriasis treatments: Those with psoriatic arthritis were more focused on the probability of benefit (P = .037), those with CVD worried about the probability of side effects (P = .046), and those with depression were concerned about treatment duration (P = .047), and cost (P = .023) (J Am Acad Dermatol. 2012 Oct 19;67[3]:363-72).

Because psoriasis is also associated with higher prevalence and incidence rates of type 2 diabetes and metabolic syndrome, particularly in patients with severe psoriasis, Dr. Jackson recommended screening for these diseases when monitoring patients during their follow-up visits (JAMA Dermatol. 2013 Jan;149[1]:84-91).

“Metabolic syndrome gives you more trouble controlling psoriasis and vice versa,” Dr. Jackson said. “It’s important to tell patients that the better health they are in, the better their medicines will work, and the better response their psoriasis will have.”

Dr. Jackson has financial ties to several pharmaceutical companies, including AbbVie, Amgen, Dermira, Galdera, Merck, Novartis, Pfizer, and others.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

Vidyard Video

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

Vidyard Video

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

Vidyard Video

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – More than 30 years after isotretinoin became available for the treatment of acne, what are some of the tropes that still hold true? And what misperceptions persist? In a video interview, Dr. Julie C. Harper, a private practitioner in Birmingham, Ala., shares the most up-to-date evidence for and against the drug’s use in patients with acne, including a look at the risk for depression and inflammatory bowel disease, among other tips for prescribing this drug in practice. She was interviewed at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – Are your patients noncompliant about sun protection? Do they want to use photoprotection but aren’t sure what is best for them? Perhaps they are confused by the multitude of sunscreen manufacturer’s claims or even some claims by consumer and environmental advocates.

Patients are often confused by how much sun protection factor they actually need and marketing hype often makes things worse, according to Dr. Vincent DeLeoof the department of dermatology at the University of Southern California, Los Angeles. “The use of the words ‘babies, natural, hypoallergenic, or organic’ all mean absolutely nothing when it comes to an SPF’s actual efficacy,” he said at the meeting provided by Global Academy of Medical Education.

The degree of confusion surrounding these products was illustrated in a survey of 114 patients at Chicago dermatology clinic. Of those surveyed, 80% said they purchased a sunscreen product to prevent sunburn (75%) and to prevent skin cancer (66%); having the highest SPF, a sensitive skin formulation, or being water resistant were reasons the products were chosen. But 62% could not identify information explaining its role in cancer prevention, and 77% could not identify how well the product would prevent sunburn. And nearly all participants were unsure how products prevented photoaging (JAMA Dermatol. 2015 Sep;151[9]:1028-30).

Adding to the confusion, Dr. DeLeo said, are warnings issued by some consumer advocacy groups about sunscreens that are not based on actual clinical or animal studies, but from data simulation. For example, he said there are no data to substantiate claims from such groups that oxybenzone has estrogenic effects in humans.

Consumer advocacy groups who say that sunscreens interfere with vitamin D levels may have a point, however, Dr. DeLeo noted, adding that it is time public health officials look into this issue, particularly with regards to revising recommended levels of vitamin D upward for the elderly, dark-skinned persons, and breastfed babies.

Although the Food and Drug Administration does not directly test sunscreens, it issued a 2014 guidance to manufacturers regarding which ingredients can be used and at what concentrations. Based on the FDA’s 2011 final rule on Labeling and Effectiveness Testing of OTC sunscreen products, the highest SPF currently allowed is “50+” without specifying actual numbers above 50, although Dr. DeLeo said this could be revised if industry is able to demonstrate efficacy at higher SPF values.

In an interview, however, he said that this is not likely to happen anytime soon. Citing a recent study of 40 commercially available sunscreens, including top brand names, professional skincare lines, and eponymously labeled products sold at drug store chains, more than half failed to reach the SPF level they purported to have and nine did not provide adequate broad spectrum protection.

“The takeaway is that the FDA is probably correct. Sunscreens should not be labeled higher than 50,” he said.

With the Sunscreen Innovation Act passed in 2014, the FDA is now evaluating data on new sunscreen agents that have proven effective overseas. So far, these agents have not been approved, Dr. DeLeo said in the interview.

With regards to the currently available products, “what patients really need to know is pretty simple,” Dr. DeLeo said during his presentation. An important point is that sunscreens – which work by forming a film on the stratum corneum, preventing the penetration of radiation – are effective only if used properly, he said.

©Vesna Andjic/iStockphoto.com

A concept that is helpful for patients to understand is that while an SPF 30 product allows a person to stay in the sun twice as long as an SPF 15 product, with the same amount of protection from burning, it does not block twice as many burn rays, he noted. “When you combine them, it’s not additive, it dilutes” he said. For example, if an SPF 10 product is mixed with an SPF 20 product, the SPF is 15.

According to Dr. DeLeo, other important messages about sunscreen for patients are as follows:

• Use SPF 30 or higher.

• Apply 20-30 minutes before exposure to give the product a chance to create an effective barrier on the skin; and reapply every 2 hours or after going in the water or sweating outside.

• Use lotions or sprays, based on patient preference.

• For pregnant women or parents who don’t want to use chemical sunscreens, inorganic physical screens can be considered, although they will likely be less effective.

• Babies younger than 6 months of age can tolerate very small amounts of sunscreens.

Still, Dr. DeLeo said that the most foolproof form of photoprotection is to stay out of the sun, particularly between 10 a.m. and 4 p.m.

He disclosed being a consultant to LaRoche-Posay and Estée Lauder. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – Are your patients noncompliant about sun protection? Do they want to use photoprotection but aren’t sure what is best for them? Perhaps they are confused by the multitude of sunscreen manufacturer’s claims or even some claims by consumer and environmental advocates.

Patients are often confused by how much sun protection factor they actually need and marketing hype often makes things worse, according to Dr. Vincent DeLeoof the department of dermatology at the University of Southern California, Los Angeles. “The use of the words ‘babies, natural, hypoallergenic, or organic’ all mean absolutely nothing when it comes to an SPF’s actual efficacy,” he said at the meeting provided by Global Academy of Medical Education.

The degree of confusion surrounding these products was illustrated in a survey of 114 patients at Chicago dermatology clinic. Of those surveyed, 80% said they purchased a sunscreen product to prevent sunburn (75%) and to prevent skin cancer (66%); having the highest SPF, a sensitive skin formulation, or being water resistant were reasons the products were chosen. But 62% could not identify information explaining its role in cancer prevention, and 77% could not identify how well the product would prevent sunburn. And nearly all participants were unsure how products prevented photoaging (JAMA Dermatol. 2015 Sep;151[9]:1028-30).

Adding to the confusion, Dr. DeLeo said, are warnings issued by some consumer advocacy groups about sunscreens that are not based on actual clinical or animal studies, but from data simulation. For example, he said there are no data to substantiate claims from such groups that oxybenzone has estrogenic effects in humans.

Consumer advocacy groups who say that sunscreens interfere with vitamin D levels may have a point, however, Dr. DeLeo noted, adding that it is time public health officials look into this issue, particularly with regards to revising recommended levels of vitamin D upward for the elderly, dark-skinned persons, and breastfed babies.

Although the Food and Drug Administration does not directly test sunscreens, it issued a 2014 guidance to manufacturers regarding which ingredients can be used and at what concentrations. Based on the FDA’s 2011 final rule on Labeling and Effectiveness Testing of OTC sunscreen products, the highest SPF currently allowed is “50+” without specifying actual numbers above 50, although Dr. DeLeo said this could be revised if industry is able to demonstrate efficacy at higher SPF values.

In an interview, however, he said that this is not likely to happen anytime soon. Citing a recent study of 40 commercially available sunscreens, including top brand names, professional skincare lines, and eponymously labeled products sold at drug store chains, more than half failed to reach the SPF level they purported to have and nine did not provide adequate broad spectrum protection.

“The takeaway is that the FDA is probably correct. Sunscreens should not be labeled higher than 50,” he said.

With the Sunscreen Innovation Act passed in 2014, the FDA is now evaluating data on new sunscreen agents that have proven effective overseas. So far, these agents have not been approved, Dr. DeLeo said in the interview.

With regards to the currently available products, “what patients really need to know is pretty simple,” Dr. DeLeo said during his presentation. An important point is that sunscreens – which work by forming a film on the stratum corneum, preventing the penetration of radiation – are effective only if used properly, he said.

©Vesna Andjic/iStockphoto.com

A concept that is helpful for patients to understand is that while an SPF 30 product allows a person to stay in the sun twice as long as an SPF 15 product, with the same amount of protection from burning, it does not block twice as many burn rays, he noted. “When you combine them, it’s not additive, it dilutes” he said. For example, if an SPF 10 product is mixed with an SPF 20 product, the SPF is 15.

According to Dr. DeLeo, other important messages about sunscreen for patients are as follows:

• Use SPF 30 or higher.

• Apply 20-30 minutes before exposure to give the product a chance to create an effective barrier on the skin; and reapply every 2 hours or after going in the water or sweating outside.

• Use lotions or sprays, based on patient preference.

• For pregnant women or parents who don’t want to use chemical sunscreens, inorganic physical screens can be considered, although they will likely be less effective.

• Babies younger than 6 months of age can tolerate very small amounts of sunscreens.

Still, Dr. DeLeo said that the most foolproof form of photoprotection is to stay out of the sun, particularly between 10 a.m. and 4 p.m.

He disclosed being a consultant to LaRoche-Posay and Estée Lauder. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – Are your patients noncompliant about sun protection? Do they want to use photoprotection but aren’t sure what is best for them? Perhaps they are confused by the multitude of sunscreen manufacturer’s claims or even some claims by consumer and environmental advocates.

Patients are often confused by how much sun protection factor they actually need and marketing hype often makes things worse, according to Dr. Vincent DeLeoof the department of dermatology at the University of Southern California, Los Angeles. “The use of the words ‘babies, natural, hypoallergenic, or organic’ all mean absolutely nothing when it comes to an SPF’s actual efficacy,” he said at the meeting provided by Global Academy of Medical Education.

The degree of confusion surrounding these products was illustrated in a survey of 114 patients at Chicago dermatology clinic. Of those surveyed, 80% said they purchased a sunscreen product to prevent sunburn (75%) and to prevent skin cancer (66%); having the highest SPF, a sensitive skin formulation, or being water resistant were reasons the products were chosen. But 62% could not identify information explaining its role in cancer prevention, and 77% could not identify how well the product would prevent sunburn. And nearly all participants were unsure how products prevented photoaging (JAMA Dermatol. 2015 Sep;151[9]:1028-30).

Adding to the confusion, Dr. DeLeo said, are warnings issued by some consumer advocacy groups about sunscreens that are not based on actual clinical or animal studies, but from data simulation. For example, he said there are no data to substantiate claims from such groups that oxybenzone has estrogenic effects in humans.

Consumer advocacy groups who say that sunscreens interfere with vitamin D levels may have a point, however, Dr. DeLeo noted, adding that it is time public health officials look into this issue, particularly with regards to revising recommended levels of vitamin D upward for the elderly, dark-skinned persons, and breastfed babies.

Although the Food and Drug Administration does not directly test sunscreens, it issued a 2014 guidance to manufacturers regarding which ingredients can be used and at what concentrations. Based on the FDA’s 2011 final rule on Labeling and Effectiveness Testing of OTC sunscreen products, the highest SPF currently allowed is “50+” without specifying actual numbers above 50, although Dr. DeLeo said this could be revised if industry is able to demonstrate efficacy at higher SPF values.

In an interview, however, he said that this is not likely to happen anytime soon. Citing a recent study of 40 commercially available sunscreens, including top brand names, professional skincare lines, and eponymously labeled products sold at drug store chains, more than half failed to reach the SPF level they purported to have and nine did not provide adequate broad spectrum protection.

“The takeaway is that the FDA is probably correct. Sunscreens should not be labeled higher than 50,” he said.

With the Sunscreen Innovation Act passed in 2014, the FDA is now evaluating data on new sunscreen agents that have proven effective overseas. So far, these agents have not been approved, Dr. DeLeo said in the interview.

With regards to the currently available products, “what patients really need to know is pretty simple,” Dr. DeLeo said during his presentation. An important point is that sunscreens – which work by forming a film on the stratum corneum, preventing the penetration of radiation – are effective only if used properly, he said.

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A concept that is helpful for patients to understand is that while an SPF 30 product allows a person to stay in the sun twice as long as an SPF 15 product, with the same amount of protection from burning, it does not block twice as many burn rays, he noted. “When you combine them, it’s not additive, it dilutes” he said. For example, if an SPF 10 product is mixed with an SPF 20 product, the SPF is 15.

According to Dr. DeLeo, other important messages about sunscreen for patients are as follows:

• Use SPF 30 or higher.

• Apply 20-30 minutes before exposure to give the product a chance to create an effective barrier on the skin; and reapply every 2 hours or after going in the water or sweating outside.

• Use lotions or sprays, based on patient preference.

• For pregnant women or parents who don’t want to use chemical sunscreens, inorganic physical screens can be considered, although they will likely be less effective.

• Babies younger than 6 months of age can tolerate very small amounts of sunscreens.

Still, Dr. DeLeo said that the most foolproof form of photoprotection is to stay out of the sun, particularly between 10 a.m. and 4 p.m.

He disclosed being a consultant to LaRoche-Posay and Estée Lauder. Global Academy and this news organization are owned by the same parent company.

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