A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream with Resveratrol , Replenix Power of Three Cream with Resveratrol with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, utilized to treat subjects with Facial Acne Vulgaris
Acne vulgaris is a common skin problem which can be challenging to treat. Enhancing the efficacy and tolerability of treatment regimens can enhance compliance and outcomes thereby potentially decreasing the morbidities associated with acne vulgaris. The present study is designed to assess the ability of Power of 3 with resveratrol to improve efficacy and tolerability of an existing combination acne medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids
FDA approved topical agent for the treatment of acne
Yardley Dermatology Associates, PC
Yardley, Pennsylvania, United States
Investigator Global Assessment (IGA)
To assess the change in Acne Vulgaris on a scale of 1 to 4, where 1 represents clear skin and 4 represents severe acne, at each scheduled visit with the use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Global Assessment (SGA)
To assess the change in Acne Vulgaris on a scale of 1 to 5, where 1 represents a worsening of acne and 5 represents clearing of acne, at each scheduled visit as compared to baseline with the use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Overall Assessment of Tone and Texture (SOATT)
To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Investigator Overall Assessment of Tone and Texture (IOATT)
To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Assessment of Skin Dysesthesia (SDA)
To assess the change in Dysesthesia on a scale of 1 to 7, where 1 represents no dysesthesia and 7 represents severe dysesthesia, at each scheduled visit with use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Quality of Life (SQOL)
To assess the change in Subject Quality of Life on a scale of 1 to 7, where 1 represents better quality of life and 7 represents worse quality of life, at Screening, Baseline and week 12 with use of Replenix Power of three with Resveratrol.
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Time frame: Screening, Baseline, Week 12
Local Tolerability Assessment
To assess the change in Local Tolerability on a scale of 0 to 3, where 0 represents no tolerability issues and 3 represents severe tolerability issues, at each scheduled visit with use of Replenix Power of three with Resveratrol.
Time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12