Acne VulgarisPhase 4NCT02249104
A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris
A Phase 4 study testing Adapalene/benzoyl peroxide gel, 0.1%/2.5% and Cetaphil Acne Regimen in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.
Trial summary
The goal of this study is to evaluate a complete topical acne regimen consisting of a prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil® DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer SPF 30) for safety, efficacy and patient satisfaction in… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene/benzoyl peroxide gel, 0.1%/2.5% and Cetaphil Acne Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and females aged 12 years and older who are actively participating in one of 14 Texas University Interscholastic League (UIL) sanctioned athletic activities at the baseline visit (Baseball; Basketball; Cross Country; Football; Golf; Soccer; Softball; Swimming and Diving; Team Tennis; Tennis; Track and Field; Volleyball; and Wrestling).
- Subjects who agree to be photographed at each visit.
- Diagnosed with acne vulgaris by a BCD and eligible for treatment with Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% per PI.
- Female subjects must have a negative urine pregnancy test (UPT) at Baseline/Visit 1, must be willing to have this test performed at the clinic, and must agree to practice one form of effective methods of non-hormonal contraception for the duration of the study which include: abstinence, IUD (inserted 30 days prior to baseline), double-barrier method, bilateral tubal ligation, or vasectomized partner (at least 90 days prior to baseline).
- A minimum of 20 but not more than 50 inflammatory (papules and pustules) lesions on the face (excluding the nose) and a minimum of 30 but not more than 100 noninflammatory lesions (open comedones and closed comedones) on the face (excluding the nose).
- Agree to use the provided study products as their only acne treatment, facial wash and facial moisturizer for the duration of the study.
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- Agree to refrain from temporary and permanent tattoos, paint, or other facial art (including, but not limited to piercings), cosmetic procedures and devices (including, but not limited to facial peels, microdermabrasion and Clarisonic®) on the face for the duration of the study.
- Subjects aged 12-17 must be willing to read and provide written informed consent/assent in conjunction with a parent/legal guardian who is able and willing to read and provide written consent prior to any study related procedure or subjects aged 18 and older must be willing to read and provide written informed consent prior to any study related procedures.
- Subjects apprised of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and applicable state Bill of Rights and are willing to share personal information and data, as verified by signing a written authorization at Screening.
- Subjects must be willing and able to attend study visits and fulfill dosing requirements.
- Subjects able to follow study instructions and likely to complete all required visits. In particular, subjects must agree to adhere to the visit schedule and be compliant with the treatment regimen.
Who cannot join
- Subjects with nodules and cysts.
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with facial hair, abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness.
- Subjects with any systemic or dermatological disorder, a known history of allergies or other medical conditions, which in the opinion of the principal investigator/BCD, could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
- Subjects with any known allergies to any of the ingredients listed on the study product labels (refer to study product"s PI and/or current labelling).
- Subjects who have participated in another interventional, investigational drug or device research study within 30 days of enrollment.
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- Study site staff or sponsor staff, relatives of site staff or sponsor, or other individuals who would have access to the clinical study protocol.
- Subjects with a washout period less than 1 week for over-the-counter topical acne treatments (with active ingredients such as Benzoyl Peroxide, Salicylic Acid, Sulfur and Resorcinol), prescription topical acne treatment and topical corticosteroids, and use of cosmetic devices (such as Clarisonic® or similar) and less than 4 weeks for topical retinoids.
- Subjects with a washout period less than 4 weeks for systemic prescription acne treatment and systemic corticosteroids and less than 24 weeks for oral retinoids.
- Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated.
- Subjects who are at risk in terms of precautions, warnings, and contra-indications (refer to the study product"s PI and current labelling).
- Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
- Subjects with any visible skin condition or facial hair that could interfere with the evaluations.
- Subjects taking or planning to take topical or systemic medications to treat acne during the course of the study.
- Subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/BCD, could interfere with the test results including any regimen of steroidal/non-steroidal anti-inflammatory drugs, or antihistamines, or anabolic steroids.
- Subjects currently under the treatment for asthma or diabetes (insulin-dependent only).
- Subjects with planned surgical or cosmetic procedures of the face during the course of the study.
- Subjects with a history of procedures such as microdermabrasion, chemical peels, intense pulsed light, fillers, Botox®, lasers, photodynamic therapy, red and blue light therapy, etc. in the last 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pflugerville Dermatology Clinical Research
Pflugerville, Texas, 78660
About this study
Official title: Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump, Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foam Wash Regimen in Student Athletes With Mild to Moderate Acne Vulgaris
The goal of this study is to evaluate a complete topical acne regimen consisting of a prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil® DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.
Read the detailed description
The overall purpose of this study was to demonstrate lesion count reduction from baseline, subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to baseline. The objective of this study was to evaluate the change in lesion count (total, inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene/benzoyl peroxide gel, 0.1%/2.5%, Cetaphil Acne Regimen
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene/benzoyl peroxide gel, 0.1%/2.5%Drug
Also called Epiduo
Topical AV therapy
Cetaphil Acne RegimenOther
Also called Cetaphil DermaControl Foam Wash, Cetaphil DermaControl Moisturizer SPF 30
Cleanse, Moisturize, and Protect
| Study group | Role | What they receive |
|---|---|---|
| Acne treatment | Experimental | Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily Receives: Drug: Adapalene/benzoyl peroxide gel, 0.1%/2.5%; Other: Cetaphil Acne Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Total Lesion Count
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Percent Change From Baseline in Total Lesion Count
Measured: Baseline and 8 weeks
Mean Change From Baseline in Inflammatory Lesion Count
Measured: Baseline and 8 weeks
Mean Change From Baseline in Non-inflammatory Lesion Count
Measured: Baseline and 8 weeks
Percent Change From Baseline in Inflammatory Lesion Count
Measured: Baseline and 8 weeks
Percent Change From Baseline in Non-inflammatory Lesion Count
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Lain, MD, Principal investigator, Pflugerville Dermatology Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249104
- Sponsor's protocol ID
- GLI.04.SPR.US10302
- Status last verified
- Apr 2016
- First submitted
- 23 Sep 2014
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump, Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foam Wash Regimen in Student Athletes With Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02249104
- Acronym / sponsor ID
- GLI.04.SPR.US10302
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate a complete topical acne regimen consisting of a prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil® DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.
Detailed description
The overall purpose of this study was to demonstrate lesion count reduction from baseline, subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to baseline. The objective of this study was to evaluate the change in lesion count (total, inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne treatment | Experimental | Drug: Adapalene/benzoyl peroxide gel, 0.1%/2.5%, Other: Cetaphil Acne RegimenAdapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male and females aged 12 years and older who are actively participating in one of 14 Texas University Interscholastic League (UIL) sanctioned athletic activities at the baseline visit (Baseball; Basketball; Cross Country; Football; Golf; Soccer; Softball; Swimming and Diving; Team Tennis; Tennis; Track and Field; Volleyball; and Wrestling).
- Subjects who agree to be photographed at each visit.
- Diagnosed with acne vulgaris by a BCD and eligible for treatment with Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% per PI.
- Female subjects must have a negative urine pregnancy test (UPT) at Baseline/Visit 1, must be willing to have this test performed at the clinic, and must agree to practice one form of effective methods of non-hormonal contraception for the duration of the study which include: abstinence, IUD (inserted 30 days prior to baseline), double-barrier method, bilateral tubal ligation, or vasectomized partner (at least 90 days prior to baseline).
- A minimum of 20 but not more than 50 inflammatory (papules and pustules) lesions on the face (excluding the nose) and a minimum of 30 but not more than 100 noninflammatory lesions (open comedones and closed comedones) on the face (excluding the nose).
Key exclusion criteria (18 listed)
- Subjects with nodules and cysts.
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with facial hair, abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness.
- Subjects with any systemic or dermatological disorder, a known history of allergies or other medical conditions, which in the opinion of the principal investigator/BCD, could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
- Subjects with any known allergies to any of the ingredients listed on the study product labels (refer to study product"s PI and/or current labelling).
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 |
|---|---|---|
| Adapalene/benzoyl peroxide gel, 0.1%/2.5%Also: EpiduoTopical AV therapy | Drug | Acne treatment |
| Cetaphil Acne RegimenAlso: Cetaphil DermaControl Foam Wash, Cetaphil DermaControl Moisturizer SPF 30Cleanse, Moisturize, and Protect | Other | Acne treatment |
Primary outcome
Mean Change From Baseline in Total Lesion Count
Time frame: Baseline and 8 weeks
5 secondary outcomes
Percent Change From Baseline in Total Lesion Count
Time frame: Baseline and 8 weeks
Mean Change From Baseline in Inflammatory Lesion Count
Time frame: Baseline and 8 weeks
Mean Change From Baseline in Non-inflammatory Lesion Count
Time frame: Baseline and 8 weeks
Percent Change From Baseline in Inflammatory Lesion Count
Time frame: Baseline and 8 weeks
Percent Change From Baseline in Non-inflammatory Lesion Count
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Edward Lain, MD principal investigator
Pflugerville Dermatology Clinical Research
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 Adapalene/benzoyl peroxide gel, 0.1%/2.5% and Cetaphil Acne Regimen in people with Acne Vulgaris, run by Galderma R&D 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 11 inclusion and 18 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: finished, as of the sponsor's last update on 23 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Total Lesion Count (time frame: Baseline and 8 weeks). 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 Aug 2022.