Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

Not Applicable

Completed

• Conditions: Skin Smoothness; Radiance; Overall Appearance

• Registration Number: NCT06633731
• Lead Sponsor: Revision Skincare

Brief Summary

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

Detailed Description

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Study Timeline

• Study Start: 2023-04-24
• Primary Completion: 2024-03-19
• Study Completion: 2024-03-19
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

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

Inclusion Criteria

• Individuals with Fitzpatrick Skin Type V and VI
• Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
• Individuals willing to undergo a washout period of 3 days.

Exclusion Criteria

• Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
• Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Lack of Significant Change in Investigator Tolerability Parameters versus Baseline	12 weeks	The primary tolerability endpoint will be favorable analysis of Investigator Tolerability grading of erythema, edema and dryness completed by study investigator at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Change in Investigator Clinical Efficacy Grading versus Baseline	12 weeks	The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Efficacy Grading of radiance, skin smoothness, and overall appearance using a Modified Griffith's 10-point scale at week 4, week 8, and week 12 versus baseline (0:None, 9=Severe). A reduction in score indicates improvement.
Lack of Significant Change in Subjective Tolerability versus Baseline	12 weeks	The secondary tolerability endpoint will be favorable analysis of Subject Tolerability grading of burning, itching, and stinging completed by subjects at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Clinical Photography: VISIA-CR and Antera 3D	12 weeks	The secondary efficacy endpoint will be favorable analysis of clinical photography including VISIA® and Antera 3D® digital imaging at week 4, 8, and 12 versus baseline. A reduction in visual radiance, skin smoothness, and overall appearance on post-baseline timepoints compared to baseline is indicated an improvement
Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement	12 weeks	The secondary endpoint will be favorable analysis of Self-Assessment Questionnaires completed by subjects at baseline, week 4, week 8, and week 12. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). A change in response values at weeks 4, 8, and 12 compared to baseline response values indicates an improvement. The best outcome is to Completely Agree with the statement / question being asked.

Trial Locations

Locations (1)

Tone Dermatology; 🇺🇸 Chicago, Illinois, United States