Acne VulgarisPhase 3NCT00422240

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

A Phase 3 study testing Adapalene/Benzoyl Peroxide, Adapalene Gel, 0.1% and Benzoyl Peroxide Gel 2.5% in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

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

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Adapalene/Benzoyl Peroxide, Adapalene Gel, 0.1% and Benzoyl Peroxide Gel 2.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,668 participants
Where: 1 siteUnited States
Study dates: 27 Jun 2006to 12 Jul 2007
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 inflammatory lesions
A minimum of 30 but not more than 100 noninflammatory lesions
A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Miller MD
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Conditions: Acne Vulgaris
Being tested: Adapalene/Benzoyl Peroxide, Adapalene Gel, 0.1%, Benzoyl Peroxide Gel 2.5%, Gel Vehicle
Keywords: Acne vulgaris, Adapalene, Benzoyl Peroxide
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
Adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
Adapalene Gel, 0.1%Drug
0.1% of adapalene gel topically daily in the evening for 12 Weeks.
Benzoyl Peroxide Gel 2.5%Drug
2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
Gel VehicleDrug
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Study groups in NCT00422240
Study group	Role	What they receive
Adapalene/Benzoyl Peroxide Gel	Experimental	Participants were treated with adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. Receives: Drug: Adapalene/Benzoyl Peroxide
Adapalene Gel, 0.1%	Experimental	Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. Receives: Drug: Adapalene Gel, 0.1%
Benzoyl Peroxide Gel 2.5%	Experimental	Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. Receives: Drug: Benzoyl Peroxide Gel 2.5%
Gel Vehicle	Placebo comparator	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. Receives: Drug: Gel Vehicle

What is being measured

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

Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Measured: At Week 12
Change in Inflammatory Lesion Count From Baseline to Week 12
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Measured: Baseline to Week 12
Change in Noninflammatory Lesion Count From Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Measured: Baseline to Week 12

Secondary outcomes (3)

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Measured: Baseline, Week 12
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Measured: Baseline, Week 12
Percent Change From Baseline in Total Lesion Counts at Week 12
The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.
Measured: Baseline, Week 12

Timeline

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

27 Jun 200612 Jul 2007

First posted15 Jan 2007 (estimated)
Study start27 Jun 2006
Primary completion12 Jul 2007
Study completion12 Jul 2007

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,668 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00422240
Sponsor's protocol ID: RD.06.SPR.18087
Status last verified: Oct 2023
First submitted: 11 Jan 2007
Last updated: 15 Apr 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.
PubMed 12963896
Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6.
PubMed 19746769

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT00422240
Acronym / sponsor ID: RD.06.SPR.18087
Conditions: Acne Vulgaris
Keywords: Acne vulgaris, Adapalene, Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,668 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 27 Jun 2006 (actual)
Primary completion: 12 Jul 2007 (actual)
Study completion: 12 Jul 2007 (actual)
First posted: 15 Jan 2007 (estimated)
Results: Posted 15 Apr 2024

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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Adapalene/Benzoyl Peroxide Gel	Experimental	Drug: Adapalene/Benzoyl PeroxideParticipants were treated with adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
Adapalene Gel, 0.1%	Experimental	Drug: Adapalene Gel, 0.1%Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
Benzoyl Peroxide Gel 2.5%	Experimental	Drug: Benzoyl Peroxide Gel 2.5%Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
Gel Vehicle	Placebo comparator	Drug: Gel VehicleParticipants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 inflammatory lesions
A minimum of 30 but not more than 100 noninflammatory lesions
A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Key exclusion criteria (0 listed)

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 PeroxideAdapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.	Drug	Adapalene/Benzoyl Peroxide Gel
Adapalene Gel, 0.1%0.1% of adapalene gel topically daily in the evening for 12 Weeks.	Drug	Adapalene Gel, 0.1%
Benzoyl Peroxide Gel 2.5%2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.	Drug	Benzoyl Peroxide Gel 2.5%
Gel VehicleParticipants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Drug	Gel Vehicle

Primary outcome

Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
Time frame: At Week 12
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Change in Inflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline to Week 12
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Change in Noninflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

3 secondary outcomes

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Total Lesion Counts at Week 12
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 15 Apr 2024, 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 Gel	415	347
Adapalene Gel, 0.1%	420	363
Benzoyl Peroxide Gel 2.5%	415	372
Gel Vehicle	418	347

Primary outcome: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)

Time frame: At Week 12. Number. Unit: percentage of participants

Measure	Adapalene/Benzoyl Peroxide Gel n = 415	Adapalene Gel, 0.1% n = 420	Benzoyl Peroxide Gel 2.5% n = 415	Gel Vehicle n = 417
Value	30.1	19.8	22.2	11.3

Population analysed: ITT (Intent-To-Treat) Population included all treated participants. Here, Overall Number of Participants Analyzed = Participants with available data for this outcome measure.

Primary outcome: Change in Inflammatory Lesion Count From Baseline to Week 12

Time frame: Baseline to Week 12. Median (Inter-Quartile Range). Unit: lesions

Measure	Adapalene/Benzoyl Peroxide Gel n = 415	Adapalene Gel, 0.1% n = 420	Benzoyl Peroxide Gel 2.5% n = 415	Gel Vehicle n = 418
Baseline	27.0 (23 to 35)	27.0 (23 to 34)	27.0 (23 to 34)	27.0 (22 to 35)
Change at Week 12	-16.0 (-22 to -10)	-14.0 (-20 to -7)	-16.0 (-21 to -7)	-10.0 (-16 to -2)

Population analysed: ITT Population included all treated participants.

Primary outcome: Change in Noninflammatory Lesion Count From Baseline to Week 12

Time frame: Baseline to Week 12. Median (Inter-Quartile Range). Unit: lesions

Measure	Adapalene/Benzoyl Peroxide Gel n = 415	Adapalene Gel, 0.1% n = 420	Benzoyl Peroxide Gel 2.5% n = 415	Gel Vehicle n = 418
Baseline	44.0 (36 to 62)	47.0 (37 to 61)	46.0 (36 to 63)	46.0 (36 to 62)
Change at Week 12	-24.0 (-35 to -13)	-22.0 (-34 to -11)	-20.0 (-32 to -7)	-14.0 (-25 to -1)

Population analysed: ITT Population included all treated participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of the study drug administration up to Week 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene/Benzoyl Peroxide Gel	2 of 415 (0.5%)	44 of 415 (10.6%)	0 of 415
Adapalene Gel, 0.1%	3 of 420 (0.7%)	51 of 420 (12.1%)	0 of 420
Benzoyl Peroxide Gel 2.5%	0 of 415 (0%)	29 of 415 (7%)	0 of 415
Gel Vehicle	1 of 418 (0.2%)	34 of 418 (8.1%)	0 of 418

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12963896Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.
Derived from this study: PubMed 19746769Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6.
Related InfoLink provided by the sponsor.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adapalene/Benzoyl Peroxide, Adapalene Gel, 0.1% and Benzoyl Peroxide Gel 2.5% 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 4 inclusion and 0 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 15 Apr 2024. 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. 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 15 Apr 2024). 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?

Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) (time frame: At Week 12). The study lists 3 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 NCT00422240, which also lists 2 linked publications.

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 15 Apr 2024.