Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Smoothness
- Sponsor
- Revision Skincare
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Clinical Photography: VISIA-CR and Antera 3D(12 weeks)
- Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement(12 weeks)