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

NCT ID: NCT06157853

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2022-08-23

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.

Conditions

Photoaging; Wrinkle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active Post-Procedure Cream

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency Microneedling

Intervention Type: 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.

Facial Cleanser

Intervention Type: 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).

Facial Moisturizer

Intervention Type: 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.

Sunscreen

Intervention Type: 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.

Comparator Anhydrous Cream

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.

Group Type: OTHER

Radiofrequency Microneedling

Intervention Type: 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.

Facial Cleanser

Intervention Type: 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).

Facial Moisturizer

Intervention Type: 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.

Sunscreen

Intervention Type: 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.

Interventions

Radiofrequency Microneedling

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.

Intervention Type: PROCEDURE

Facial Cleanser

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).

Intervention Type: OTHER

Facial Moisturizer

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.

Intervention Type: OTHER

Sunscreen

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.

Intervention Type: OTHER

Other Intervention Names

Fractional biopolar radiofrequency microneedling, InMode; Neutrogena Sheer Zinc SPF 50

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Revision Skincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Micahel Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Tennesse Clinical Research Center

Locations

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

RVSN-05-222

Identifier Type: -

Identifier Source: org_study_id