Acne VulgarisPhase 4NCT03563365
The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol
A Phase 4 study testing Replenix Power of 3 Cream with resveratrol and Adapalene and Benzoyl peroxide gel, 0.1%/2.5% in people with Acne Vulgaris, run by Yardley Dermatology Associates at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Replenix Power of 3 Cream with resveratrol and Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 2 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yardley Dermatology Associates, PC
Yardley, Pennsylvania, 19067
About this study
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
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
Read the 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
- Being tested
- Replenix Power of 3 Cream with resveratrol, Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replenix Power of 3 Cream with resveratrolOther
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%Drug
FDA approved topical agent for the treatment of acne
| Study group | Role | What they receive |
|---|---|---|
| Replenix | Experimental | Replenix power of 3 cream with Resveratrol applied twice daily Receives: Other: Replenix Power of 3 Cream with resveratrol |
| Replenix and Adapalene and Benzoyl Peroxide gel | Experimental | Replenix power of 3 cream with Resveratrol applied twice daily and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily Receives: Other: Replenix Power of 3 Cream with resveratrol; Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5% |
| Adapalene and Benzoyl Peroxide gel | Active comparator | Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily Receives: Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
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.
Measured: Screening, Baseline, Week 12
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.
Measured: Screening, Baseline, Week 2, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start4 Jun 2018
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yardley Dermatology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Topix Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Michelle Sibona, Yardley Dermatology Associates
- Investigators
- Richard G Fried, MD, PhD, Principal investigator, Yardley Dermatology Associates, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563365
- Sponsor's protocol ID
- TPX-PW3-2018-A
- Status last verified
- Apr 2021
- First submitted
- 23 May 2018
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03563365
- Acronym / sponsor ID
- TPX-PW3-2018-A
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yardley Dermatology AssociatesUniversity, hospital or other
- Collaborators
- Topix Pharmaceuticals, Inc
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Replenix | Experimental | Other: Replenix Power of 3 Cream with resveratrolReplenix power of 3 cream with Resveratrol applied twice daily |
| Replenix and Adapalene and Benzoyl Peroxide gel | Experimental | Other: Replenix Power of 3 Cream with resveratrol, Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%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 | Active comparator | Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replenix Power of 3 Cream with resveratrolCosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids | Other | Replenix, Replenix and Adapalene and Benzoyl Peroxide gel |
| Adapalene and Benzoyl peroxide gel, 0.1%/2.5%FDA approved topical agent for the treatment of acne | Drug | Adapalene and Benzoyl Peroxide gel, Replenix and Adapalene and Benzoyl Peroxide gel |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard G Fried, MD, PhD principal investigator
Yardley Dermatology Associates, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Replenix Power of 3 Cream with resveratrol and Adapalene and Benzoyl peroxide gel, 0.1%/2.5% in people with Acne Vulgaris, run by Yardley Dermatology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) (time frame: Screening, Baseline, Week 2, Week 4, Week 8, Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.