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

Stopped early · Phase 4

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT03563365

Run by

Yardley Dermatology Associates

People needed

43

Starts

2018-06-04

Expected to finish

2021-03-02

Last updated by the study team

2021-04-23

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
• 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).
• Investigator's Global Assessment (IGA) of acne severity grade 2 or 3
• Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
• 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

You may not qualify if…

• 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).
• Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.:
• chloracne and drug induced acne).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.
• History of hypersensitivity or allergy to benzoyl peroxide or adapalene and or any of the study product ingredients.
• Subjects who have a severe or intense irritation on the face.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
• Concomitant use of tanning booths or sunbathing.
• A significant medical history of or are currently immunocompromised
• Have any systemic or dermatologic disease that may affect the evaluation of study results.
• Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
• Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.

Where it is running

• Yardley Dermatology Associates, PC — Yardley, Pennsylvania, United States

Full record on ClinicalTrials.gov

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