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

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ClinicalTrials.gov Identifier: NCT03563365
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Topix Pharmaceuticals, Inc
Information provided by (Responsible Party):
Michelle Sibona, 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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Replenix Power of 3 Cream with resveratrol Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5% Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Masking Description: Subject is instructed not to discuss or disclose treatment arm with PI.
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : February 4, 2019
Estimated Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Replenix
Replenix power of 3 cream with Resveratrol applied twice daily
Other: 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

Experimental: 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
Other: 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

Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
FDA approved topical agent for the treatment of acne

Active Comparator: Adapalene and Benzoyl Peroxide gel
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily
Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
FDA approved topical agent for the treatment of acne




Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.

  2. Subject Global Assessment (SGA) [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.

  3. Subject Overall Assessment of Tone and Texture (SOATT) [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.

  4. Investigator Overall Assessment of Tone and Texture (IOATT) [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.

  5. Subject Assessment of Skin Dysesthesia (SDA) [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.

  6. Subject Quality of Life (SQOL) [ Time Frame: Screening, Baseline, Week 12 ]
    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.

  7. Local Tolerability Assessment [ Time Frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12 ]
    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.



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563365


Contacts
Contact: Suzanne Withrow 215-579-6155 ext 28 swithrow@yardleyderm.com
Contact: Dara Tolas 215-579-6155 ext 28 dtolas@yardleyderm.com

Locations
United States, Pennsylvania
Yardley Dermatology Associates, PC Recruiting
Yardley, Pennsylvania, United States, 19067
Contact: Michelle Clinical Trial Site Manager    215-579-6155 ext 27    msibona@yardleyderm.com   
Principal Investigator: Richard G Fried, MD, PhD         
Sub-Investigator: Lauren Sternberg, MD         
Sub-Investigator: Judith Cenci, MD         
Sub-Investigator: Priya Dhanaraj, MD         
Sponsors and Collaborators
Yardley Dermatology Associates
Topix Pharmaceuticals, Inc
Investigators
Principal Investigator: Richard G Fried, MD, PhD Yardley Dermatology Associates, PC

Responsible Party: Michelle Sibona, Principal Investigator/ Clinical Director, Yardley Dermatology Associates
ClinicalTrials.gov Identifier: NCT03563365     History of Changes
Other Study ID Numbers: TPX-PW3-2018-A
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Resveratrol
Adapalene
Benzoyl Peroxide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Dermatologic Agents