Clinical trial NCT03563365: The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Yardley Dermatology Associates
Sponsor class: OTHER
Collaborators: name: Topix Pharmaceuticals, Inc
First posted: 2018-06-20
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Investigator Global Assessment (IGA)
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
measure: Subject Global Assessment (SGA)
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
measure: Subject Overall Assessment of Tone and Texture (SOATT)
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
measure: Investigator Overall Assessment of Tone and Texture (IOATT)
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
measure: Subject Assessment of Skin Dysesthesia (SDA)
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
measure: Subject Quality of Life (SQOL)
timeFrame: Screening, Baseline, Week 12
measure: Local Tolerability Assessment
timeFrame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Yardley
country: United States
facility: Yardley Dermatology Associates, PC
state: Pennsylvania
Study officials:
affiliation: Yardley Dermatology Associates, PC
name: Richard G Fried, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: