Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated Wi… (NCT06157853) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
United States11 participantsStarted 2022-07-11
Plain-language summary
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging. Furthermore, this clinical trial will compare the active post-procedure cream to a comparator anhydrous cream product often paired with skin rejuvenation procedures.
A total of 11 healthy female subjects completed the study. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
Who can participate
Age range35 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects must be between 35-65 years of age.
✓. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
✓. Subjects with Fitzpatrick I-VI photo skin type.
✓. Subjects must have moderate photodamage (Grade II or III) using the Glogau Scale of Photoaging.
Exclusion criteria
✕. Subjects being or planning to become pregnant or breastfeeding during the study
✕. Having received a chemical peel, dermabrasion or microneedling treatment in the previous six months; laser resurfacing (ablative, non-ablative) in the previous twelve months
✕. Unwilling to refrain from pain medications post-procedure
✕. Unwilling to discontinue topical anti-aging facial products for one week prior to study commencement or on prescription strength retinoids or skin lightening produces within two months of the study.