Novel dermal coring device effective for facial rejuvenation without using thermal energy

 

DALLAS – An investigational dermal microexcisional device is an effective treatment for facial rejuvenation without the use of thermal energy and without scarring, according to preliminary results from an ongoing study.

“This differs from laser treatment in the sense that there’s no thermal injury and it takes a deep core approach, along the lines of what you might expect from a punch biopsy,” lead study author Roy G. Geronemus, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “The device causes microscale excisions below the size that causes scar. It’s mechanical only, without the use of any thermal energy. There is quantitative and directional reduction in area of skin. This leads to wrinkle improvement, tightening, smoothing of lax skin, and skin rejuvenation.”

Dr. Geronemus, director of the Laser & Skin Surgery Center of New York, presented findings from a multicenter study of 23 women who were treated bilaterally in the mid- to lower face with the 22-gauge coring device developed by Cytrellis Biosystems, while removing 5% and 7.5% of skin, respectively, in up to two treatments. Local anesthesia was used, and biopsies were taken before and after treatment at 60 and 90 days. The researchers assessed efficacy with the Lemperle wrinkle scale, the Global Aesthetic Improvement Scale, and subject satisfaction scales at 90 days.

The average age of subjects was 64 years, and all had Fitzpatrick types II or III skin. No unanticipated adverse events or serious adverse events were observed, and histology from 3 subjects showed an excellent healing profile and no scarring. The average pain during treatment was 0.36 on the 0-10 Wong-Baker scale.

Interim 90-day data demonstrated that 87% of 30 cheek areas had 1, 2, or 3 levels of improvement in moderate to severe cheek wrinkles on the Lemperle scale, according to primary investigator assessment. Investigators and subjects scored “improved to very much improved” in 93% of patients per the Global Aesthetic Improvement Scale, and 80% of the patients reported being “satisfied to extremely satisfied” with their aesthetic results.

Dr. Geronemus noted that, while it takes 2 to 7 days for wounds to close following ablative procedures, wounds close in about 10 minutes following microexcisional treatment, which possibly leads to faster healing of tissue. “Most people expect some downtime to achieve effective, long-lasting results,” he said. “The mean downtime was 3.8 days; 75% of subjects did not miss work, and 46% did not miss any social or leisure activities.”

To date, 79 subjects have been treated and a 90-day pivotal study is under way. Based on the clinical data to date, he said, “the new technique offers the ability to remove a significant amount of damaged, lax skin without concern of scarring or pigmentary change.”

Dr. Geronemus reported having served on the advisory board or as an investigator for Cynosure, Syneron Candela, Cutera, Revance Therapeutics, Allergan, Cytrellis Biosystems, the New York Stem Cell Foundation, among others. He also holds ownership interests with Cytrellis, the company that developed the coring device.

[email protected]

 

DALLAS – An investigational dermal microexcisional device is an effective treatment for facial rejuvenation without the use of thermal energy and without scarring, according to preliminary results from an ongoing study.

“This differs from laser treatment in the sense that there’s no thermal injury and it takes a deep core approach, along the lines of what you might expect from a punch biopsy,” lead study author Roy G. Geronemus, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “The device causes microscale excisions below the size that causes scar. It’s mechanical only, without the use of any thermal energy. There is quantitative and directional reduction in area of skin. This leads to wrinkle improvement, tightening, smoothing of lax skin, and skin rejuvenation.”

Dr. Geronemus, director of the Laser & Skin Surgery Center of New York, presented findings from a multicenter study of 23 women who were treated bilaterally in the mid- to lower face with the 22-gauge coring device developed by Cytrellis Biosystems, while removing 5% and 7.5% of skin, respectively, in up to two treatments. Local anesthesia was used, and biopsies were taken before and after treatment at 60 and 90 days. The researchers assessed efficacy with the Lemperle wrinkle scale, the Global Aesthetic Improvement Scale, and subject satisfaction scales at 90 days.

The average age of subjects was 64 years, and all had Fitzpatrick types II or III skin. No unanticipated adverse events or serious adverse events were observed, and histology from 3 subjects showed an excellent healing profile and no scarring. The average pain during treatment was 0.36 on the 0-10 Wong-Baker scale.

Interim 90-day data demonstrated that 87% of 30 cheek areas had 1, 2, or 3 levels of improvement in moderate to severe cheek wrinkles on the Lemperle scale, according to primary investigator assessment. Investigators and subjects scored “improved to very much improved” in 93% of patients per the Global Aesthetic Improvement Scale, and 80% of the patients reported being “satisfied to extremely satisfied” with their aesthetic results.

Dr. Geronemus noted that, while it takes 2 to 7 days for wounds to close following ablative procedures, wounds close in about 10 minutes following microexcisional treatment, which possibly leads to faster healing of tissue. “Most people expect some downtime to achieve effective, long-lasting results,” he said. “The mean downtime was 3.8 days; 75% of subjects did not miss work, and 46% did not miss any social or leisure activities.”

To date, 79 subjects have been treated and a 90-day pivotal study is under way. Based on the clinical data to date, he said, “the new technique offers the ability to remove a significant amount of damaged, lax skin without concern of scarring or pigmentary change.”

Dr. Geronemus reported having served on the advisory board or as an investigator for Cynosure, Syneron Candela, Cutera, Revance Therapeutics, Allergan, Cytrellis Biosystems, the New York Stem Cell Foundation, among others. He also holds ownership interests with Cytrellis, the company that developed the coring device.

[email protected]

 

DALLAS – An investigational dermal microexcisional device is an effective treatment for facial rejuvenation without the use of thermal energy and without scarring, according to preliminary results from an ongoing study.

“This differs from laser treatment in the sense that there’s no thermal injury and it takes a deep core approach, along the lines of what you might expect from a punch biopsy,” lead study author Roy G. Geronemus, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “The device causes microscale excisions below the size that causes scar. It’s mechanical only, without the use of any thermal energy. There is quantitative and directional reduction in area of skin. This leads to wrinkle improvement, tightening, smoothing of lax skin, and skin rejuvenation.”

Dr. Geronemus, director of the Laser & Skin Surgery Center of New York, presented findings from a multicenter study of 23 women who were treated bilaterally in the mid- to lower face with the 22-gauge coring device developed by Cytrellis Biosystems, while removing 5% and 7.5% of skin, respectively, in up to two treatments. Local anesthesia was used, and biopsies were taken before and after treatment at 60 and 90 days. The researchers assessed efficacy with the Lemperle wrinkle scale, the Global Aesthetic Improvement Scale, and subject satisfaction scales at 90 days.

The average age of subjects was 64 years, and all had Fitzpatrick types II or III skin. No unanticipated adverse events or serious adverse events were observed, and histology from 3 subjects showed an excellent healing profile and no scarring. The average pain during treatment was 0.36 on the 0-10 Wong-Baker scale.

Interim 90-day data demonstrated that 87% of 30 cheek areas had 1, 2, or 3 levels of improvement in moderate to severe cheek wrinkles on the Lemperle scale, according to primary investigator assessment. Investigators and subjects scored “improved to very much improved” in 93% of patients per the Global Aesthetic Improvement Scale, and 80% of the patients reported being “satisfied to extremely satisfied” with their aesthetic results.

Dr. Geronemus noted that, while it takes 2 to 7 days for wounds to close following ablative procedures, wounds close in about 10 minutes following microexcisional treatment, which possibly leads to faster healing of tissue. “Most people expect some downtime to achieve effective, long-lasting results,” he said. “The mean downtime was 3.8 days; 75% of subjects did not miss work, and 46% did not miss any social or leisure activities.”

To date, 79 subjects have been treated and a 90-day pivotal study is under way. Based on the clinical data to date, he said, “the new technique offers the ability to remove a significant amount of damaged, lax skin without concern of scarring or pigmentary change.”

Dr. Geronemus reported having served on the advisory board or as an investigator for Cynosure, Syneron Candela, Cutera, Revance Therapeutics, Allergan, Cytrellis Biosystems, the New York Stem Cell Foundation, among others. He also holds ownership interests with Cytrellis, the company that developed the coring device.

[email protected]