Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated Wi… (NCT06366503) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
United States23 participantsStarted 2023-10-03
Plain-language 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.
Who can participate
Age range35 Years – 65 Years
SexFEMALE
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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