evaluating procedure pairing of a post-procedure cream versus a comparator in patients treated with fractional ablative co2 laser for facial rejuvenation

Conditions: Photoaging; Wrinkle; Skin Laxity

Summary: this randomized, single-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 fractional ablative co2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point modified griffiths' scale). furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. this is a cosmetic study with a fda-regulated device. a total of 22 healthy female subjects completed the study.

this randomized, single-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 fractional ablative co2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point modified griffiths' 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) and pain over the course of the study. furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. a 14-day washout period was required of all subjects prior to co2 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, 7, and 14 post-procedure. pain evaluations were completed by subjects using the 11-point wong baker faces® pain rating scale post-procedure, post-procedure/post-product application, and days 1, 3, 5, 7, and 14 post-procedure. in addition, efficacy evaluation using the modified griffiths' scale was performed at screening, pre-procedure, and days 1, 3, 5, 7, and 14 post-procedure. self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 3, and 14 post-procedure. clinical photography was completed at all timepoints (screening to day 14 post-procedure). a total of 22 subjects completed study participation.

Eligibility criteria:
inclusion criteria: * healthy female subjects 35-65 years of age * fitzpatrick skin type i to iii * any race or ethnicity * moderate to severe overall photodamage (global face) (score of 4 to 9 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, microdermabrasion, hydro dermabrasion or anti-aging facial within 1 month; non-ablative laser (including ipl) or non-ablative fractional laser resurfacing of the face within 6 months; ablative laser resurfacing of the face within 12 months. * not willing to discontinue active topical facial products for 14 days prior to the baseline visit

Keywords: post-procedure fractional ablative co2 laser