AcnePhase 4NCT01138735

Epiduo Pediatric Acne Study

A Phase 4 study testing adapalene/benzoyl peroxide in people with Acne, run by Galderma R&D at 25 sites in 2 countries.

Completed

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

Trial summary

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris. Read more about this study

Who is it for?: Ages 9 to 11 years
Conditions the study is for: Acne
What is being tested?: adapalene/benzoyl peroxide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 285 participants
Where: 25 sitesin 2 countries
Study dates: Jun 2010to Aug 2011
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 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Clinical diagnosis of acne vulgaris with facial involvement
Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Who cannot join

Acne nodule or acne cyst
Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States20 sites

UAB Dermatology Clinical Research
Birmingham, Alabama, 35233
Cininnati Children's Hospital
Cincinnati, Ohio, 45229
Henry Ford Health Systems Department of Dermatology
Detroit, Michigan, 48202
Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
Fridley, Minnesota, 55432
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
Hershey, Pennsylvania, 17033
Zoe Draelos, MD
High Point, North Carolina, 27262
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, 37660
Dermatology Specialists Research
Louisville, Kentucky, 40202
FXM Research Miramar
Miramar, Florida, 33027
Skin Specialists, PC
Omaha, Nebraska, 68144
Adult & Pediatric Dermatology
Overland Park, Kansas, 66211
Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
San Diego, California, 92123
Redwood Family Dermatology
Santa Rosa, California, 95403
Haber Dermatology Clinical Research Center
South Euclid, Ohio, 44118
Premier Clinical Research
Spokane, Washington, 99204
Central Dermatology PC
St Louis, Missouri, 63117
Dermcenter PC - Somerset Skin Centre
Troy, Michigan, 48084
Department of Dermatology - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

Ultranova Skincare
Barrie, Ontario, L4M 6L2
Lynderm Research, Inc
Markham, Ontario, L3P 1A8
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7

Other trials in Canada

About this study

Official title: A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris

Conditions: Acne
Being tested: adapalene/benzoyl peroxide, Topical Gel Vehicle
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 peroxideDrug
Also called Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%
daily topical application for 12 weeks
Topical Gel VehicleDrug
daily topical application for 12 weeks

Study groups in NCT01138735
Study group	Role	What they receive
adapalene/benzoyl peroxide	Active comparator	Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks Receives: Drug: adapalene/benzoyl peroxide
Topical Gel Vehicle	Placebo comparator	Topical Gel Vehicle applied topically once daily for 12 weeks Receives: Drug: Topical Gel Vehicle

What is being measured

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

Success Rate
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
Measured: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Change From Baseline in Total Lesion Counts
Measured: Baseline to Week 12 (LOCF)

Secondary outcomes (2)

Percent Change in Total Lesion Counts From Baseline
Measured: Baseline to Week 12 (LOCF)
Change in Inflammatory Lesion Counts From Baseline
Measured: Baseline to Week 12 (LOCF)

Timeline

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

Jun 2010Aug 2011

First posted7 Jun 2010 (estimated)
Study startJun 2010
Primary completionAug 2011
Study completionAug 2011

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01138735
Sponsor's protocol ID: RD.06.SPR.18155
Status last verified: Apr 2013
First submitted: 4 Jun 2010
Last updated: 18 Feb 2021
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

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All Acne trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris
ClinicalTrials.gov ID: NCT01138735
Acronym / sponsor ID: RD.06.SPR.18155
Conditions: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 7 Jun 2010 (estimated)
Results: Posted 26 Mar 2013

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
adapalene/benzoyl peroxide	Active comparator	Drug: adapalene/benzoyl peroxideEpiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle	Placebo comparator	Drug: Topical Gel VehicleTopical Gel Vehicle applied topically once daily for 12 weeks

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Clinical diagnosis of acne vulgaris with facial involvement
Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Key exclusion criteria (4 listed)

Acne nodule or acne cyst
Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

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 peroxideAlso: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%daily topical application for 12 weeks	Drug	adapalene/benzoyl peroxide
Topical Gel Vehicledaily topical application for 12 weeks	Drug	Topical Gel Vehicle

Primary outcome

Success Rate
Time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
Change From Baseline in Total Lesion Counts
Time frame: Baseline to Week 12 (LOCF)

2 secondary outcomes

Percent Change in Total Lesion Counts From Baseline
Time frame: Baseline to Week 12 (LOCF)
Change in Inflammatory Lesion Counts From Baseline
Time frame: Baseline to Week 12 (LOCF)

Results and safety

Results posted to the registry on 26 Mar 2013, 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/Benzoyl Peroxide	142	134
Topical Gel Vehicle	143	126

Primary outcome: Success Rate

Time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF]). Number. Unit: percentage of participant

Measure	Adapalene/Benzoyl Peroxide n = 142	Topical Gel Vehicle n = 143
Value	47.2	15.4

Adapalene/Benzoyl Peroxide vs Topical Gel Vehicle: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent to treat (ITT) population, LOCF

Primary outcome: Change From Baseline in Total Lesion Counts

Time frame: Baseline to Week 12 (LOCF). Mean (Standard Deviation). Unit: lesion count change

Measure	Adapalene/Benzoyl Peroxide n = 142	Topical Gel Vehicle n = 143
Value	-27.6 (22.43)	-3.6 (24.44)

Adapalene/Benzoyl Peroxide vs Topical Gel Vehicle: p <0.001, ANCOVA

Population analysed: ITT population, LOCF

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene/Benzoyl Peroxide	0 of 142 (0%)	37 of 142 (26.1%)	Not reported
Topical Gel Vehicle	1 of 143 (0.7%)	18 of 143 (12.6%)	Not reported

Limitations and caveats (from the sponsor): LOCF data were used for primary efficacy and secondary efficacy data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne

Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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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.

Michael Graeber, MD study director

Galderma R&D

Lorne Albrecht, MD principal investigator

Guildford Dermatology Specialists

Zoe Draelos, MD principal investigator

Zoe Draelos, MD

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adapalene/benzoyl peroxide in people with Acne, run by Galderma R&D at 25 sites in 2 countries.

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 3 inclusion and 4 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 Mar 2013). 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?

Success Rate (time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])). The study lists 2 primary outcomes in all. 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 NCT01138735.

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 18 Feb 2021.