A Clinical Study To Evaluate the Efficacy and Tolerance of a Topical Facial Treatment on Women With Mild to Moderate Fine Lines, Wrinkles, and Laxity on the Global Face
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fine Lines
- Sponsor
- Revision Skincare
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change Investigator Clinical Efficacy Grading versus Baseline
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This single-center clinical 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, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.
Detailed Description
This single-center clinical 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, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. 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
- •Having Fitzpatrick Skin Type I - VI
- •Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).
Exclusion Criteria
- •Breastfeeding, pregnant, or planning to become pregnant during the study.
- •Currently having or having a history of cold sores (Herpes simplex) on the face.
Outcomes
Primary Outcomes
Change Investigator Clinical Efficacy Grading versus Baseline
Time Frame: 12 weeks
The primary efficacy endpoint will be Investigator Clinical Efficacy grading of parameters at baseline, post-application, and weeks 4, 8, and 12. the efficacy parameters will be assessed by the expert grader on each subjects global face using a modified Griffiths 10-point scale. A decrease in score indicates an improvement.
Lack of significant change in Investigator Tolerability Parameters versus Baseline
Time Frame: 12 weeks
The primary tolerability endpoint will be Investigator Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by the expert grader by assessing the signs of erythema and dryness using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Lack of significant change in Subjective Tolerability versus Baseline
Time Frame: 12 weeks
The primary tolerability endpoint will be Subjective Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by subject reporting of the degree of burning, stinging, and itching globally on each subject's global face using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Secondary Outcomes
- Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement(12 weeks)
- Clinical Photography: VISIA-CR and Antera 3D(12 weeks)