The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol

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

Sponsors

Lead Sponsor: Yardley Dermatology Associates

Collaborator: Topix Pharmaceuticals, Inc

Source Yardley Dermatology Associates
Brief Summary

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

Detailed Description

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.

Overall Status Terminated
Start Date 2018-06-04
Completion Date 2021-03-02
Primary Completion Date 2021-03-02
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Investigator Global Assessment (IGA) Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Global Assessment (SGA) Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Overall Assessment of Tone and Texture (SOATT) Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Investigator Overall Assessment of Tone and Texture (IOATT) Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Assessment of Skin Dysesthesia (SDA) Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Subject Quality of Life (SQOL) Screening, Baseline, Week 12
Local Tolerability Assessment Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Enrollment 43
Condition
Intervention

Intervention Type: Other

Intervention Name: Replenix Power of 3 Cream with resveratrol

Description: Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids

Intervention Type: Drug

Intervention Name: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%

Description: FDA approved topical agent for the treatment of acne

Eligibility

Criteria:

Inclusion Criteria: 1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris 2. On the face, ≥ 20 non-inflammatory lesions (i.e., open and closed comedones) AND < 75 inflammatory lesions (i.e., papules and pustules) AND ≤ 1 nodulocystic lesions (i.e., nodules and cysts). 3. Investigator's Global Assessment (IGA) of acne severity grade 2 or 3 4. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. 5. Subject/Guardian must sign an IRB-approved Informed Consent/Assent/Assent Form including photography consent, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed Exclusion Criteria: 1. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 2. Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne). 3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed. 4. History of hypersensitivity or allergy to benzoyl peroxide or adapalene and or any of the study product ingredients. 5. Subjects who have a severe or intense irritation on the face. 6. Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). 7. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study. 8. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. 9. Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oralretinoids, which require a 6-month washout), or 5) systemic anti- inflammatory agents. 10. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics. 11. Subjects who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization). 12. Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. 13. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. 14. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study. 15. Concomitant use of tanning booths or sunbathing. 16. A significant medical history of or are currently immunocompromised 17. Have any systemic or dermatologic disease that may affect the evaluation of study results. 18. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis. 19. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.

Gender:

All

Minimum Age:

12 Years

Maximum Age:

40 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Richard G Fried, MD, PhD Principal Investigator Yardley Dermatology Associates, PC
Overall Contact

Last Name: Suzanne Withrow

Phone: 215-579-6155

Phone Ext.: 28

Email: [email protected]

Location
Facility: Yardley Dermatology Associates, PC
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Yardley Dermatology Associates

Investigator Full Name: Michelle Sibona

Investigator Title: Principal Investigator/ Clinical Director

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Replenix

Type: Experimental

Description: Replenix power of 3 cream with Resveratrol applied twice daily

Label: Replenix and Adapalene and Benzoyl Peroxide gel

Type: Experimental

Description: Replenix power of 3 cream with Resveratrol applied twice daily and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily

Label: Adapalene and Benzoyl Peroxide gel

Type: Active Comparator

Description: Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Masking Description: Subject is instructed not to discuss or disclose treatment arm with PI.

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