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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Photoaging, Wrinkle

Intervention / Treatment
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* Procedure: Radiofrequency Microneedling
* Other: Facial Cleanser
* Other: Facial Moisturizer
* Other: Sunscreen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single-center, double-blinded, controlled.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Post-Procedure Cream<br>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<br>* 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.<br>* Other names: Fractional biopolar radiofrequency microneedling, InMode;Other: Facial Cleanser<br>* 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).<br>Other: Facial Moisturizer<br>* 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.<br>Other: Sunscreen<br>* 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.<br>* Other names: Neutrogena Sheer Zinc SPF 50;|
| Other: Comparator Anhydrous Cream<br>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<br>* 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.<br>* Other names: Fractional biopolar radiofrequency microneedling, InMode;Other: Facial Cleanser<br>* 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).<br>Other: Facial Moisturizer<br>* 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.<br>Other: Sunscreen<br>* 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.<br>* Other names: Neutrogena Sheer Zinc SPF 50;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = Mild = Moderate = 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 = Mild = Moderate = Severe | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy Grading | 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. | 14 days | 
| Self-Assessment Questionnaire | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-procedure, radiofrequency microneedling