AcnePhase 4NCT01951417

Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

A Phase 4 study testing Adapalene/BPO Gel, Moisturizer SPF 30 and Foam Wash in people with Acne, run by Galderma R&D at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne
What is being tested?: Adapalene/BPO Gel, Moisturizer SPF 30 and Foam Wash
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 5 sitesUnited States
Study dates: Oct 2013to Mar 2014
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 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

Who cannot join

Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study Protocol, Inc.
Boynton Beach, Florida, 33437
Stephens & Associates
Carrollton, Texas, 75006
J&S Studies, Inc.
College Station, Texas, 77845
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris

This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.

Conditions: Acne
Being tested: Adapalene/BPO Gel, Moisturizer SPF 30, Foam Wash
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/BPO GelDrug
Also called Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump, Adapalene and benzoyl peroxide (BPO) gel
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30Other
Also called Cetaphil® DermaControl™ Moisturizer SPF 30
Moisturizer SPF 30 (once daily)
Foam WashOther
Also called Cetaphil® DermaControl™ Foam Wash
Foam Wash (twice daily)

Study groups in NCT01951417
Study group	Role	What they receive
Adapalene/BPO Gel/Foam Wash/Moisturizer	Experimental	Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily) Receives: Drug: Adapalene/BPO Gel; Other: Moisturizer SPF 30; Other: Foam Wash

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Lesion Count
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Measured: Baseline, 2, 4, and 8 weeks

Secondary outcomes (3)

Inflammatory Lesions
The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Measured: Baseline, 2, 4, and 8 weeks
Non-inflammatory Lesions
The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks
Measured: Baseline, 2, 4, and 8 weeks
Subject Questionnaire
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Measured: Baseline, 2, 4, and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2014

First posted26 Sep 2013 (estimated)
Study startOct 2013
Primary completionMar 2014
Study completionMar 2014

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 AcneStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01951417
Sponsor's protocol ID: GLI.04.SRE.04.US10268
Status last verified: Feb 2016
First submitted: 23 Sep 2013
Last updated: 23 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne trials

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™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT01951417
Acronym / sponsor ID: GLI.04.SRE.04.US10268
Conditions: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 26 Sep 2013 (estimated)
Results: Posted 14 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adapalene/BPO Gel/Foam Wash/Moisturizer	Experimental	Drug: Adapalene/BPO Gel, Other: Moisturizer SPF 30, Other: Foam WashAdapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

Key exclusion criteria (1 listed)

Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

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/BPO GelAlso: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump, Adapalene and benzoyl peroxide (BPO) gelAdapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)	Drug	Adapalene/BPO Gel/Foam Wash/Moisturizer
Moisturizer SPF 30Also: Cetaphil® DermaControl™ Moisturizer SPF 30Moisturizer SPF 30 (once daily)	Other	Adapalene/BPO Gel/Foam Wash/Moisturizer
Foam WashAlso: Cetaphil® DermaControl™ Foam WashFoam Wash (twice daily)	Other	Adapalene/BPO Gel/Foam Wash/Moisturizer

Primary outcome

Total Lesion Count
Time frame: Baseline, 2, 4, and 8 weeks
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.

3 secondary outcomes

Inflammatory Lesions
Time frame: Baseline, 2, 4, and 8 weeks
Non-inflammatory Lesions
Time frame: Baseline, 2, 4, and 8 weeks
Subject Questionnaire
Time frame: Baseline, 2, 4, and 8 weeks

Results and safety

Results posted to the registry on 14 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adapalene/BPO Gel/Foam Wash/Moisturizer	81	72

Primary outcome: Total Lesion Count

Time frame: Baseline, 2, 4, and 8 weeks. Mean (Standard Deviation). Unit: lesions

Measure	Adapalene/BPO Gel/Foam Wash/Moisturizer n = 77
Baseline	76.7 (21.1)
Week 2	53.9 (25.5)
Week 4	50.0 (27.8)
Week 8	43.7 (22.7)

Population analysed: ITT population (all subjects who had at least 1 post-treatment administration evaluation)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene/BPO Gel/Foam Wash/Moisturizer	0 of 81 (0%)	13 of 81 (16%)	Not reported

Limitations and caveats (from the sponsor): * Open label study with small sample size * Short study duration

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.

Related trials for Acne

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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.

Joshua M Berlin, MD principal investigator

Dermatology Associates, PA, of the Palm Beaches

5 sites 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/BPO Gel, Moisturizer SPF 30 and Foam Wash in people with Acne, run by Galderma R&D at 5 sites 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 1 inclusion and 1 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 5 sites 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 14 Mar 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?

Total Lesion Count (time frame: Baseline, 2, 4, and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01951417.

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.