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

Not Applicable

Completed

• Conditions: Photoaging; Wrinkle
• Interventions: Procedure: Radiofrequency Microneedling; Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen

• Registration Number: NCT06157853
• Lead Sponsor: Revision Skincare

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.

Study Timeline

• Study Start: 2022-07-11
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-23
• Status Verified: 2023-11
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Post-Procedure Cream	Sunscreen	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.
Active Post-Procedure Cream	Facial Moisturizer	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.
Active Post-Procedure Cream	Facial Cleanser	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.
Comparator Anhydrous Cream	Radiofrequency Microneedling	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.
Comparator Anhydrous Cream	Facial Moisturizer	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.
Comparator Anhydrous Cream	Sunscreen	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.
Active Post-Procedure Cream	Radiofrequency Microneedling	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.
Comparator Anhydrous Cream	Facial Cleanser	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	14-days	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.
Investigator Tolerability Scores	14 days	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
Subject Tolerability Scores	14 days	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

Secondary Outcome Measures

Name	Time	Method
Self-Assessment Questionnaire	14 days	The secondary efficacy endpoint will be the Self-Assessment Questionnaire. A change in response values at post-procedure/post-product application (Visit 2), Day 1 (Visit 3), Day 3 (Visit 4), and Day 7 (Visit 5) indicates, and improvement compared to baseline response values. Baseline responses will be set to post-procedure/post-product application. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
Clinical Efficacy Grading	14 days	To evaluate the efficacy of the neurocosmetic on self-perceived improvement and objective grading. Investigator clinical grading, using the Glogau photoaging scale performed at Visit 1 (screening), Visit 2 (baseline, 7-days post-washout), and Visit 5 (14 days).; The Global Aesthetic Improvement Scale (GAIS) to be completed at Visit 5 (14 days).; GAIS Scoring: Very much improved- Optimal cosmetic result for the treatment in this patient. Much improved- Marked improvement in appearance but not completely optimal for this patient. A touch-up would slightly improve the result.; Improved - Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.; No change- The appearance is the same as than the original condition. Worse- The appearance is worse than the original condition.

Trial Locations

Locations (1)

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States