AcnePhase 3ACCESS IINCT00687908

Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

A Phase 3 study testing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in people with Acne, run by Galderma R&D at 33 sites in 3 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. Read more about this study

Who is it for?: Ages 12 to 35 years
Conditions the study is for: Acne
What is being tested?: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 243 participants
Where: 33 sitesin 3 countries
Study dates: Nov 2008to Jul 2009
Phase: Phase 3
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 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Who cannot join

Female Subjects who are pregnant, nursing or planning a pregnancy during the study
Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Trial locations and contacts

33 sites in 3 countries.

Country

City, postcode or hospital

33 sites in 3 countries

United States27 sites

Galderma Investigational Site
Albuquerque, New Mexico
Galderma Investigational Site
Arlington, Texas
Galderma Investigational Site
Austin, Texas
Galderma Investigational Site
Chicago, Illinois
Galderma Investigational Site
College Station, Texas
Galderma Investigational Site
Denver, Colorado
Galderma Investigational Site
Detroit, Michigan
Galderma Investigational Site
Evansville, Indiana
Galderma Investigational Site
Fort Gratiot, Michigan
Galderma Investigational Site
Fridley, Minnesota
Galderma Investigational Site
Hazleton, Pennsylvania
Galderma Investigational Site
Hershey, Pennsylvania
Galderma Investigational Site
Houston, Texas
Galderma Investigational Site
Longmont, Colorado
Galderma Investigational Site
Louisville, Kentucky
Galderma Investigational Site
Lubbock, Texas
Galderma Investigational Site
Miami, Florida
Galderma Investigational Site
Omaha, Nebraska
Galderma Investigational Site
Overland Park, Kansas
Galderma Investigational Site
San Antonio, Texas
Galderma Investigational Site
San Diego, California
Galderma Investigational Site
Simpsonville, South Carolina
Galderma Investigational Site
Snellville, Georgia
Galderma Investigational Site
Stony Brook, New York
Galderma Investigational Site
Warren, Ohio
Galderma Investigational Site
Webster, Texas, 77598
Galderma Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada4 sites

Galderma Investigational Site
Barrie, Ontario
Galderma Investigational Site
North Bay, Ontario
Galderma Investigational Site
Québec, Quebec
Galderma Investigational Site
Windsor, Ontario

Other trials in Canada

Puerto Rico2 sites

Galderma Investigational Site
Aibonito
Galderma Investigational Site
Carolina

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment

Read the detailed description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Conditions: Acne
Being tested: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel, Vehicle Gel
Keywords: Acne
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 0.1% / Benzoyl Peroxide 2.5% GelDrug
Also called Adapalene-BPO gel
Topical Gel to the face, once daily in the evening for 24 weeks.
Vehicle GelDrug
Topical Gel to the face, once daily in the evening for 24 weeks.

Study groups in NCT00687908
Study group	Role	What they receive
1	Experimental	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily Receives: Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
2	Placebo comparator	Vehicle Gel once daily Receives: Drug: Vehicle Gel

What is being measured

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

Maintenance Success for Total Lesions at Week 24
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
Measured: Week 24

Secondary outcomes (4)

Maintenance Success for Inflamatory Lesions at Week 24
Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.
Measured: Week 24
Maintenance Success for Non-inflammatory Lesions at Week 24
Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
Measured: Week 24
Investigator Global Assessment (IGA) Maintenance Success at Week 24
IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.
IGA grade:
0 Clear:Residual hyperpigmentation \& erythema may be present
1. Almost Clear:A few scattered comedones \& a few small papules.
2. Mild:Some comedones \& some papules and pustules. No nodules present
3. Moderate:Many comedones, papules \& pustules. One nodule may be present
4. Severe:Covered with comedones, numerous papules \& pustules \& few nodules \& cysts may be present
5. Very severe:Highly inflammatory acne covering the face; with nodules \& cysts present
Measured: Baseline, Week 24
Percent of Subjects With Adverse Events
All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Measured: Up to 24 weeks

Timeline

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

Nov 2008Jul 2009

First posted2 Jun 2008 (estimated)
Study startNov 2008
Primary completionJul 2009
Study completionJul 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687908
Sponsor's protocol ID: RD.03.SPR.29075
Acronym: ACCESS II
Status last verified: Sep 2010
First submitted: 28 May 2008
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

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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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.
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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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: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment
ClinicalTrials.gov ID: NCT00687908
Acronym / sponsor ID: ACCESS II / RD.03.SPR.29075
Conditions: Acne
Keywords: Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 2 Jun 2008 (estimated)
Results: Posted 24 Sep 2010

Clinical summary

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

Detailed description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% GelAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
2	Placebo comparator	Drug: Vehicle GelVehicle Gel once daily

Who may qualify

Ages: 12 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Key exclusion criteria (2 listed)

Female Subjects who are pregnant, nursing or planning a pregnancy during the study
Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

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 0.1% / Benzoyl Peroxide 2.5% GelAlso: Adapalene-BPO gelTopical Gel to the face, once daily in the evening for 24 weeks.	Drug	1
Vehicle GelTopical Gel to the face, once daily in the evening for 24 weeks.	Drug	2

Primary outcome

Maintenance Success for Total Lesions at Week 24
Time frame: Week 24
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.

4 secondary outcomes

Maintenance Success for Inflamatory Lesions at Week 24
Time frame: Week 24
Maintenance Success for Non-inflammatory Lesions at Week 24
Time frame: Week 24
Investigator Global Assessment (IGA) Maintenance Success at Week 24
Time frame: Baseline, Week 24
Percent of Subjects With Adverse Events
Time frame: Up to 24 weeks

Results and safety

Results posted to the registry on 24 Sep 2010, 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	123	105
Vehicle	120	78

Primary outcome: Maintenance Success for Total Lesions at Week 24

Time frame: Week 24. Number. Unit: percent of subjects

Measure	Adapalene-BPO n = 123	Vehicle n = 120
Value	78.9	45.8

Population analysed: ITT - Worst-case (Any missing data at Week 24 is considered as a failure)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene-BPO	1 of 123 (0.8%)	43 of 123 (35%)	Not reported
Vehicle	1 of 120 (0.8%)	27 of 120 (22.5%)	Not reported

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 InfoLink provided by the sponsor.

Related trials for Acne

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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
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
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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.

Diane Thiboutot, MD principal investigator

Penn State College of Medicine, Hershey, PA

33 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in people with Acne, run by Galderma R&D at 33 sites in 3 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 1 inclusion and 2 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 33 sites in United States, Canada, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Sep 2010). 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?

Maintenance Success for Total Lesions at Week 24 (time frame: Week 24). 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 NCT00687908.

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; AzTrials last refreshed its copy on 8 Nov 2026.