evaluating procedure pairing of a post-procedure cream versus a comparator in patients treated with a hybrid-fractional laser for facial rejuvenation

Conditions: Photoaging; Wrinkle; Skin Laxity

Summary: this randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point modified griffiths' scale). furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures. this is a cosmetic study with an fda-regulated device. a total of 16 healthy female subjects completed the study (8 subjects at both sites).

this randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point modified griffith's scale). the ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters (erythema, edema, dryness, burning, itching, stinging) over the course of the study. furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures. a 7-day washout period was required of all subjects prior to hybrid-fractional laser treatment. tolerability (investigator: erythema, edema, dryness; subject: burning, itching, stinging) and safety were assessed through grading at screening, pre-procedure, post-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure. in addition, efficacy evaluation using the modified griffiths' scale was performed at screening, pre-procedure, and day 7 post-procedure. self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 5, and 7 post-procedure. clinical photography was completed at screening, pre-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure. a total of 16 healthy female subjects completed the study (8 subjects at both sites).

Eligibility criteria:
inclusion criteria: * healthy female subjects 35-65 years of age * fitzpatrick skin type i to iii * moderate to severe global face photodamage (score of 4 to 7 out of the 10-point modified griffiths' scale, where 0 = none and 9 = severe) * no known medical conditions that, in the investigator's opinion, may interfere with study participation. * willing to discontinue all active topical facial products and only use the assigned test products for the duration of the study. * female subjects of childbearing potential must be willing to use a form of birth control during the study. exclusion criteria: * nursing, pregnant, or planning a pregnancy during this study. * having undergone a chemical peel, dermabrasion, or microneedling (mechanical and radiofrequency) in the last 6 months; laser resurfacing (ablative, fractional, non-ablative) in the last 12 months * not willing to discontinue active topical facial products for 7 days prior to the baseline visit

Keywords: post-procedure hybrid fractional laser