Clinical trial NCT06157853: Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
Official title: A Randomized, Single-Center, Double-Blinded, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Wrinkle
Keywords: post-procedure
radiofrequency microneedling
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 11
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-center, double-blinded, controlled.
Primary purpose: OTHER

Brief 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.

Detailed description: 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 in improving patient downtime specifically in minimizing tolerability parameters (erythema, edema, dryness, burning, stinging, and itch) to assist in soothing skin after radiofrequency microneedling procedure.

A 7-day washout period is required for all subjects prior to radiofrequency microneedling procedure. Tolerability (investigator and subject) and safety will be assessed through grading at baseline, post-procedure, post-procedure/post-product application, twenty-four (24) hours post-procedure, three days post-procedure, and seven days post-procedure.

Tolerability parameters included erythema, edema, dryness, burning, stinging, and itch. Efficacy evaluation using the Glogau photoaging scale was performed at screening, baseline, and day 7 post-procedure. The Global Aesthetic Improvement Scale (GAIS) was performed at day 7-post procedure. Self-assessment questionnaire and clinical photography will be completed at all timepoints.

A total of 11 subjects completed study participation. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.

Eligibility criteria: Inclusion Criteria:

1. Female subjects must be between 35-65 years of age.
2. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
3. Subjects with Fitzpatrick I-VI photo skin type.
4. Subjects must have moderate photodamage (Grade II or III) using the Glogau Scale of Photoaging.

6. Subjects interested in Radiofrequency Microneedling treatments. 7. Subjects must have no skin disease in the facial area being evaluated. 8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects must be wiling to discontinue all active topical facial products and must only use the assigned study products to the face and neck for the duration of the study.

Exclusion Criteria:

1. Subjects being or planning to become pregnant or breastfeeding during the study
2. Having received a chemical peel, dermabrasion or microneedling treatment in the previous six months; laser resurfacing (ablative, non-ablative) in the previous twelve months
3. Unwilling to refrain from pain medications post-procedure
4. 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.
5. Subjects who have a Glogau Score of I or IV.

Primary outcomes:
measure: Investigator Tolerability Scores
timeFrame: 14 days
measure: Incidence of Adverse Events
timeFrame: 14-days
measure: Subject Tolerability Scores
timeFrame: 14 days
Secondary outcomes:
measure: Clinical Efficacy Grading
timeFrame: 14 days
measure: Self-Assessment Questionnaire
timeFrame: 14 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Tennesse Clinical Research Center
name: Micahel Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: