Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation

Completed · Not applicable

Conditions studied: Photoaging, Wrinkle, Skin Laxity

In brief

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).

Key facts

Study ID

NCT06436261

Run by

Revision Skincare

People needed

20

Starts

2021-12-14

Expected to finish

2022-07-01

Last updated by the study team

2024-05-31

Who can join

Age: 35 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• AYA™ Medical Spa — Atlanta, Georgia, United States
• Resurrect Skin MD — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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