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

NCT06157853 | Completed FDA Device

• 1 other identifier: RVSN-05-222
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging; Wrinkle

Keywords

post-procedure; radiofrequency microneedling

Outcome Measures

Primary Outcomes (3)

• Investigator Tolerability Scores

  The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe

  14 days

• Incidence of Adverse Events

  The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.

  14-days

• Subject Tolerability Scores

  Subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe

  14 days

Secondary Outcomes (2)

• Clinical Efficacy Grading

  14 days

• Self-Assessment Questionnaire

  14 days

Study Arms (2)

Active Post-Procedure Cream

ACTIVE COMPARATOR

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.

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

Comparator Anhydrous Cream

OTHER

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.

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

Interventions

Radiofrequency Microneedling PROCEDURE

A fractional bipolar radiofrequency microneedling device will be performed at Visit 2, after the 7-day washout period. Subjects were numbed 45 minutes prior to RF microneedling with topical numbing Benzocaine 20%/Lidocaine 6%/tetracaine 4%. Bony areas, periorbital, forehead, and chin were treated with 15 watts at a 2 mm needle depth on cycle mode. All subjects received 20 watts at 3 mm depth on cycle mode on soft tissue, neck, and cheeks.

Also known as: Fractional biopolar radiofrequency microneedling, InMode

Active Post-Procedure Cream; Comparator Anhydrous Cream

Facial Cleanser OTHER

Facial cleanser to be used by subjects twice-daily. This product was used during the entire 14-day study (7-day washout period and 7-day post-procedure timeline).

Active Post-Procedure Cream; Comparator Anhydrous Cream

Facial Moisturizer OTHER

Bland moisturizer to be used by subjects twice daily during the 7-day washout period. Use 1 to 2 pumps and place all over face and avoid the eye area.

Active Post-Procedure Cream; Comparator Anhydrous Cream

Sunscreen OTHER

Bland sunscreen to be used by subjects after cleansing and the facial moisturizer during the 7-day washout period. Bland sunscreen to be used by subjects after cleansing and after the active post-procedure cream and comparator anhydrous cream. Use the provided sunscreen and reapply as needed throughout the day and per recommendation of the FDA, every 2 hours.

Also known as: Neutrogena Sheer Zinc SPF 50

Active Post-Procedure Cream; Comparator Anhydrous Cream

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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.
• Subjects who have a Glogau Score of I or IV.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Micahel Gold, MD

  Tennesse Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be randomly assigned to one of the following treatment arms: active post-procedure cream versus comparator anhydrous cream. The products will be packaged in the same container and labelled post-procedure cream. Double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety are blinded to treatment during the 14-day randomization study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-center, double-blinded, controlled.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: July 11, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 23, 2022
• Last Updated: April 10, 2024

Record last verified: 2023-11

Locations

US (1)