Energy-based therapy plus oxymetazoline proves safe for rosacea

Energy-based therapy with adjunctive oxymetazoline was safe and improved facial erythema for patients with moderate to severe facial erythema associated with rosacea, according to results from a phase 4 study.

“The current study was designed to evaluate the safety and tolerability of oxymetazoline when used as an adjunctive treatment with energy‐based therapy for patients with moderate to severe facial erythema associated with rosacea,” wrote Emil A. Tanghetti, MD, of the Center for Dermatology and Laser Surgery in Sacramento, and coauthors. The findings were published in Lasers in Surgery and Medicine.

The open-label, interventional study included 46 patients with rosacea, with moderate to severe facial erythema. Study participants received treatment with one of four energy-based devices: pulsed‐dye laser Vbeam Perfecta (PDL-Vbeam), pulsed‐dye laser Cynergy (PDL-Cynergy), intense pulsed-light therapy (IPL), or potassium titanyl phosphate laser (KTP laser), in combination with adjunctive oxymetazoline hydrochloride cream (1%).

On days 3-27 and 31-56, oxymetazoline, an alpha_1A adrenoceptor agonist was applied once daily, while energy-based therapy was provided on day 1 and day 29.

The primary safety endpoints were the incidence of treatment‐emergent adverse events (TEAEs) and serious adverse events; the exploratory efficacy endpoint was the change in clinician erythema assessment (CEA) score from start of therapy measured over a 6-hour period post treatment.

Among 43 evaluable patients (who completed the study), CEA score was improved in 39 (90.7%) patients 6 hours post treatment on day 56 and in 30 (68.2%) patients pretreatment.

On day 31, of the 43 evaluable patients, “one‐grade or greater improvement was observed” in 26 (60.5%) patients before application of oxymetazoline, and in 38 (88.4%) of patients 6 hours post treatment, they wrote.

Overall, patient satisfaction increased over the course of the study, with 28 (65.1%) of patients reporting they were satisfied or very satisfied with the treatment on day 56.

Among 46 patients who received at least one treatment, 5 (10.9%) patients had one or more TEAEs (KTP laser, n = 1; PDL-Vbeam, n = 4), and 4 patients had one or more treatment‐related TEAEs (PDL-Vbeam, n = 4); All TEAEs were considered mild or moderate. “Three (6.5%) patients experienced TEAEs related to oxymetazoline; all led to study discontinuation,” the researchers reported.

The researchers acknowledged that a key limitation of the study was the use of multiple energy-based devices, delivered by different providers, which could have caused inconsistency in the results.

“Prospective clinical studies assessing the long‐term safety and efficacy of combined treatment with oxymetazoline and energy‐based therapies are needed,” they concluded.

The manuscript was funded by oxymetazoline manufacturer Aclaris Therapeutics. Several authors disclosed being an investigator, consultant, and/or laser manufacturers. One author was an employee of Aclaris at the time of the study.

SOURCE: Tanghetti EA et al. Lasers Surg Med. 2020 May 6. doi: 10.1002/lsm.23253.

Energy-based therapy with adjunctive oxymetazoline was safe and improved facial erythema for patients with moderate to severe facial erythema associated with rosacea, according to results from a phase 4 study.

“The current study was designed to evaluate the safety and tolerability of oxymetazoline when used as an adjunctive treatment with energy‐based therapy for patients with moderate to severe facial erythema associated with rosacea,” wrote Emil A. Tanghetti, MD, of the Center for Dermatology and Laser Surgery in Sacramento, and coauthors. The findings were published in Lasers in Surgery and Medicine.

The open-label, interventional study included 46 patients with rosacea, with moderate to severe facial erythema. Study participants received treatment with one of four energy-based devices: pulsed‐dye laser Vbeam Perfecta (PDL-Vbeam), pulsed‐dye laser Cynergy (PDL-Cynergy), intense pulsed-light therapy (IPL), or potassium titanyl phosphate laser (KTP laser), in combination with adjunctive oxymetazoline hydrochloride cream (1%).

On days 3-27 and 31-56, oxymetazoline, an alpha_1A adrenoceptor agonist was applied once daily, while energy-based therapy was provided on day 1 and day 29.

The primary safety endpoints were the incidence of treatment‐emergent adverse events (TEAEs) and serious adverse events; the exploratory efficacy endpoint was the change in clinician erythema assessment (CEA) score from start of therapy measured over a 6-hour period post treatment.

Among 43 evaluable patients (who completed the study), CEA score was improved in 39 (90.7%) patients 6 hours post treatment on day 56 and in 30 (68.2%) patients pretreatment.

On day 31, of the 43 evaluable patients, “one‐grade or greater improvement was observed” in 26 (60.5%) patients before application of oxymetazoline, and in 38 (88.4%) of patients 6 hours post treatment, they wrote.

Overall, patient satisfaction increased over the course of the study, with 28 (65.1%) of patients reporting they were satisfied or very satisfied with the treatment on day 56.

Among 46 patients who received at least one treatment, 5 (10.9%) patients had one or more TEAEs (KTP laser, n = 1; PDL-Vbeam, n = 4), and 4 patients had one or more treatment‐related TEAEs (PDL-Vbeam, n = 4); All TEAEs were considered mild or moderate. “Three (6.5%) patients experienced TEAEs related to oxymetazoline; all led to study discontinuation,” the researchers reported.

The researchers acknowledged that a key limitation of the study was the use of multiple energy-based devices, delivered by different providers, which could have caused inconsistency in the results.

“Prospective clinical studies assessing the long‐term safety and efficacy of combined treatment with oxymetazoline and energy‐based therapies are needed,” they concluded.

The manuscript was funded by oxymetazoline manufacturer Aclaris Therapeutics. Several authors disclosed being an investigator, consultant, and/or laser manufacturers. One author was an employee of Aclaris at the time of the study.

SOURCE: Tanghetti EA et al. Lasers Surg Med. 2020 May 6. doi: 10.1002/lsm.23253.

Energy-based therapy with adjunctive oxymetazoline was safe and improved facial erythema for patients with moderate to severe facial erythema associated with rosacea, according to results from a phase 4 study.

“The current study was designed to evaluate the safety and tolerability of oxymetazoline when used as an adjunctive treatment with energy‐based therapy for patients with moderate to severe facial erythema associated with rosacea,” wrote Emil A. Tanghetti, MD, of the Center for Dermatology and Laser Surgery in Sacramento, and coauthors. The findings were published in Lasers in Surgery and Medicine.

The open-label, interventional study included 46 patients with rosacea, with moderate to severe facial erythema. Study participants received treatment with one of four energy-based devices: pulsed‐dye laser Vbeam Perfecta (PDL-Vbeam), pulsed‐dye laser Cynergy (PDL-Cynergy), intense pulsed-light therapy (IPL), or potassium titanyl phosphate laser (KTP laser), in combination with adjunctive oxymetazoline hydrochloride cream (1%).

On days 3-27 and 31-56, oxymetazoline, an alpha_1A adrenoceptor agonist was applied once daily, while energy-based therapy was provided on day 1 and day 29.

The primary safety endpoints were the incidence of treatment‐emergent adverse events (TEAEs) and serious adverse events; the exploratory efficacy endpoint was the change in clinician erythema assessment (CEA) score from start of therapy measured over a 6-hour period post treatment.

Among 43 evaluable patients (who completed the study), CEA score was improved in 39 (90.7%) patients 6 hours post treatment on day 56 and in 30 (68.2%) patients pretreatment.

On day 31, of the 43 evaluable patients, “one‐grade or greater improvement was observed” in 26 (60.5%) patients before application of oxymetazoline, and in 38 (88.4%) of patients 6 hours post treatment, they wrote.

Overall, patient satisfaction increased over the course of the study, with 28 (65.1%) of patients reporting they were satisfied or very satisfied with the treatment on day 56.

Among 46 patients who received at least one treatment, 5 (10.9%) patients had one or more TEAEs (KTP laser, n = 1; PDL-Vbeam, n = 4), and 4 patients had one or more treatment‐related TEAEs (PDL-Vbeam, n = 4); All TEAEs were considered mild or moderate. “Three (6.5%) patients experienced TEAEs related to oxymetazoline; all led to study discontinuation,” the researchers reported.

The researchers acknowledged that a key limitation of the study was the use of multiple energy-based devices, delivered by different providers, which could have caused inconsistency in the results.

“Prospective clinical studies assessing the long‐term safety and efficacy of combined treatment with oxymetazoline and energy‐based therapies are needed,” they concluded.

The manuscript was funded by oxymetazoline manufacturer Aclaris Therapeutics. Several authors disclosed being an investigator, consultant, and/or laser manufacturers. One author was an employee of Aclaris at the time of the study.

SOURCE: Tanghetti EA et al. Lasers Surg Med. 2020 May 6. doi: 10.1002/lsm.23253.