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

NCT ID: NCT03563365

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2021-03-02

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Replenix

Replenix power of 3 cream with Resveratrol applied twice daily

Group Type: EXPERIMENTAL

Replenix Power of 3 Cream with resveratrol

Intervention Type: OTHER

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

Replenix and Adapalene and Benzoyl Peroxide gel

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

Group Type: EXPERIMENTAL

Replenix Power of 3 Cream with resveratrol

Intervention Type: OTHER

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

Adapalene and Benzoyl peroxide gel, 0.1%/2.5%

Intervention Type: DRUG

FDA approved topical agent for the treatment of acne

Adapalene and Benzoyl Peroxide gel

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

Group Type: ACTIVE_COMPARATOR

Adapalene and Benzoyl peroxide gel, 0.1%/2.5%

Intervention Type: DRUG

FDA approved topical agent for the treatment of acne

Interventions

Replenix Power of 3 Cream with resveratrol

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

Intervention Type: OTHER

Adapalene and Benzoyl peroxide gel, 0.1%/2.5%

FDA approved topical agent for the treatment of acne

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Topix Pharmaceuticals, Inc

UNKNOWN

Sponsor Role: collaborator

Yardley Dermatology Associates

OTHER

Sponsor Role: lead

Responsible Party

Michelle Sibona

Principal Investigator/ Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard G Fried, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yardley Dermatology Associates, PC

Locations

Yardley Dermatology Associates, PC

Yardley, Pennsylvania, United States

Countries

United States

Other Identifiers

TPX-PW3-2018-A

Identifier Type: -

Identifier Source: org_study_id