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

Primary Purpose

Acne Vulgaris

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Replenix Power of 3 Cream with resveratrol
Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
Sponsored by
Yardley Dermatology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yardley Dermatology Associates, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Replenix

Replenix and Adapalene and Benzoyl Peroxide gel

Adapalene and Benzoyl Peroxide gel

Arm Description

Replenix power of 3 cream with Resveratrol applied twice daily

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

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

Outcomes

Primary Outcome Measures

Investigator Global Assessment (IGA)
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.
Subject Global Assessment (SGA)
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.
Subject Overall Assessment of Tone and Texture (SOATT)
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.
Investigator Overall Assessment of Tone and Texture (IOATT)
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.
Subject Assessment of Skin Dysesthesia (SDA)
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.
Subject Quality of Life (SQOL)
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.
Local Tolerability Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2018
Last Updated
April 20, 2021
Sponsor
Yardley Dermatology Associates
Collaborators
Topix Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03563365
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of Funding
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yardley Dermatology Associates
Collaborators
Topix Pharmaceuticals, Inc

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Investigator
Masking Description
Subject is instructed not to discuss or disclose treatment arm with PI.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Replenix
Arm Type
Experimental
Arm Description
Replenix power of 3 cream with Resveratrol applied twice daily
Arm Title
Replenix and Adapalene and Benzoyl Peroxide gel
Arm Type
Experimental
Arm Description
Replenix power of 3 cream with Resveratrol applied twice daily and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily
Arm Title
Adapalene and Benzoyl Peroxide gel
Arm Type
Active Comparator
Arm Description
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily
Intervention Type
Other
Intervention Name(s)
Replenix Power of 3 Cream with resveratrol
Intervention 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(s)
Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
Intervention Description
FDA approved topical agent for the treatment of acne
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA)
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Title
Subject Global Assessment (SGA)
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Title
Subject Overall Assessment of Tone and Texture (SOATT)
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Title
Investigator Overall Assessment of Tone and Texture (IOATT)
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Title
Subject Assessment of Skin Dysesthesia (SDA)
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Title
Subject Quality of Life (SQOL)
Description
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.
Time Frame
Screening, Baseline, Week 12
Title
Local Tolerability Assessment
Description
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.
Time Frame
Screening, Baseline, Week 2, Week 4, Week 8, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard G Fried, MD, PhD
Organizational Affiliation
Yardley Dermatology Associates, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yardley Dermatology Associates, PC
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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