Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation

Revision Skincare

Status: Completed

Conditions: Photoaging; Wrinkle

Treatments: Other: Sunscreen; Procedure: Radiofrequency Microneedling; Other: Facial Moisturizer; Other: Facial Cleanser

Study type: Interventional

Funder types: Industry

Identifiers

NCT06157853

RVSN-05-222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

5. 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Active Post-Procedure Cream

Active Comparator group

Description:

Dosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants. Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck. Study duration: 14 days. Active Post-Procedure Cream duration 7-days.

Treatment:

Procedure: Radiofrequency Microneedling

Other: Facial Cleanser

Other: Facial Moisturizer

Other: Sunscreen

Comparator Anhydrous Cream

Other group

Description:

Dosage Form: anhydrous cream containing peptides, and antioxidants. Frequency of Dosage: Twice daily (morning and evening). Subjects will be asked to massage 2 to 3 pumps of test material onto face, forehead, under eyes, cheeks, upper lips, chin, nose, and neck. Study duration: 14 days. Comparator Anhydrous Cream duration 7-days.

Treatment:

Procedure: Radiofrequency Microneedling

Other: Facial Cleanser

Other: Facial Moisturizer

Other: Sunscreen