Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT06366503
Brief 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.
Detailed Description:
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.
Study:
NCT06366503
Study Brief:
Protocol Section:
NCT06366503