Acne VulgarisPhase 3NCT00421993
A 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 and Benzoyl Peroxide in people with Acne Vulgaris, run by Galderma R&D at 62 sites in 5 countries.
Trial summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. 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, Adapalene and Benzoyl Peroxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,670 participants
- Where
- 62 sitesin 5 countries
- Study dates
- Oct 2006to Dec 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
- More than one acne nodule or any acne cyst.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- Underlying diseases that require the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period is documented
- Use of hormonal contraceptives solely for control of acne
Trial locations and contacts
62 sites in 5 countries.
62 sites in 5 countries
United States33 sites
Atlanta Dermatology and Vein Research Center
Alpharetta, Georgia, 30005
Radiant Research
Anderson, South Carolina, 29621
Arlington Center for Dermatology
Arlington, Texas, 76011
Dolby Research, LLC
Baton Rouge, Louisiana, 70809
Fletcher Allen Health Care
Burlington, Vermont, 05401
UTSW Medical Center at Dallas
Dallas, Texas, 75390-9190
Welborn Clinic
Evansville, Indiana, 47713
Associates in research, Inc.
Fresno, California, 93720
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
James Del Rosso, DO - Office of Dr. James Del Russo
Henderson, Nevada, 89052
Zoe Draelos
High Point, North Carolina, 27262
Medical Affliated Research Center
Huntsville, Alabama, 35801
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
University of California, Irvine
Irvine, California, 92697-1385
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37934
Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Tanner Clinic
Layton, Utah, 84041
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
SKINQRI
Lincolnshire, Illinois, 60069
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Dermatology Research Associates
Los Angeles, California, 90045
Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
Marina del Rey, California, 90292
Skin Specialty Group
New York, New York, 10021
OU Health Sciences Center - Dept. of Dermatology
Oklahoma City, Oklahoma, 73104
Hamzavi Dermatology
Port Huron, Michigan, 48060
Affiliated Research Institute
San Diego, California, 92108
University at San Francisco Medical Center
San Francisco, California, 94143
Radiant Research
Santa Rosa, California, 95405
Dr Weintraub James
Simi Valley, California, 93065
Derm Research Center of NY, Inc.
Stony Brook, New York, 11790-2598
Somerset Skin Clinic
Troy, Michigan, 48084
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Visions Clinical Research
West Palm Beach, Florida, 33406
Canada15 sites
Ultranova Skin care
Barrie, Ontario, L4M 6L2
The Dermatology Centre
Calgary, Alberta, T2S 3B3
Stratica Medical
Edmonton, Alberta, T5K 1X3
Innovaderm Research Laval Inc.
Laval, Quebec, H7S 2C6
Lynderm Research inc.
Markham, Ontario, L3P 1A8
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Siena Medical Research
Montreal, Quebec, H3G1C6
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Nexus clinical research
St. John's, Newfoundland and Labrador, A1B 3E1
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1B 4S8
Guildford Dermatology Specialists
Surrey, British Columbia, BC V3R 6A7
Derm Research @ 888 Inc.
Vancouver, British Columbia, V5Z 3Y1
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4
Germany8 sites
Licca Clinical Research Institute
Augsburg, 86179
Henrik Pres
Berlin, 10435
Meike Schroeder
Berlin, 14169
Beatrice Gerlach
Dresden, 01097
Kloverkorn, Windfried
Gilching, 82205
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, 39120
Michael Sebastian
Mahlow, 15831
Thomas Dirschka
Wuppertal, 42275
Hungary3 sites
Outpatient Dermatology Department DUH
Budapest, 1036
Margit Simola
Budapest, 1084
Outpatient Dermatilogy Department XIX District
Budapest, 1195
Poland3 sites
Waldemar Placek
Bydgoszcz, 85096
DERMED Specjalistyczne Gabinety Lekarskie
Lodz, 90265
Wojceiech Silny
Poznan, 60355
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 is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be 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 subject should remain the same during the study.
The primary objective is 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, Benzoyl Peroxide, Topical 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
Topical Gel, One application daily in the evening for 12 weeks
AdapaleneDrug
Topical Gel,One application daily in the evening for 12 weeks
Benzoyl PeroxideDrug
Topical Gel, one application daily in the evening for 12 weeks
Topical Gel VehicleDrug
Topical Gel Vehicle,one application daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adapalene/Benzoyl Peroxide Topical Gel Receives: Drug: Adapalene/Benzoyl Peroxide |
| 2 | Active comparator | Adapalene Topical Gel Receives: Drug: Adapalene |
| 3 | Active comparator | Benzoyl Peroxide Topical Gel Receives: Drug: Benzoyl Peroxide |
| 4 | Placebo comparator | Topical Gel Vehicle Receives: Drug: Topical Gel Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate on the Investigator's Global Assessment
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Measured: at week 12
Changes in Inflammatory Lesion Counts
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Measured: from Baseline to week 12
Changes in Noninflammatory Lesion Counts
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Measured: from Baseline to week 12
Secondary outcomes (3)
Percent Change in Inflammatory Lesion Counts
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Measured: at week 12
Percent Change in Noniflammatory Lesion Counts
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Measured: at week 12
Percent Change in Total Lesion Counts
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionDec 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 (1)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421993
- Sponsor's protocol ID
- RD.06.SPR.18088
- Status last verified
- Oct 2009
- First submitted
- 11 Jan 2007
- Last updated
- 18 Feb 2021
- 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
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, 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
- NCT00421993
- Acronym / sponsor ID
- RD.06.SPR.18088
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Adapalene, Benzoyl Peroxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Posted 11 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be 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 subject should remain the same during the study.
The primary objective is 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Adapalene/Benzoyl PeroxideAdapalene/Benzoyl Peroxide Topical Gel |
| 2 | Active comparator | Drug: AdapaleneAdapalene Topical Gel |
| 3 | Active comparator | Drug: Benzoyl PeroxideBenzoyl Peroxide Topical Gel |
| 4 | Placebo comparator | Drug: Topical Gel VehicleTopical Gel Vehicle |
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 (6 listed)
- More than one acne nodule or any acne cyst.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- Underlying diseases that require the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period is documented
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 PeroxideTopical Gel, One application daily in the evening for 12 weeks | Drug | 1 |
| AdapaleneTopical Gel,One application daily in the evening for 12 weeks | Drug | 2 |
| Benzoyl PeroxideTopical Gel, one application daily in the evening for 12 weeks | Drug | 3 |
| Topical Gel VehicleTopical Gel Vehicle,one application daily in the evening for 12 weeks | Drug | 4 |
Primary outcome
Success Rate on the Investigator's Global Assessment
Time frame: at week 12
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Changes in Inflammatory Lesion Counts
Time frame: from Baseline to week 12
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Changes in Noninflammatory Lesion Counts
Time frame: from Baseline to week 12
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
3 secondary outcomes
Percent Change in Inflammatory Lesion Counts
Time frame: at week 12
Percent Change in Noniflammatory Lesion Counts
Time frame: at week 12
Percent Change in Total Lesion Counts
Time frame: at week 12
Results and safety
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.
- 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.
- 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
62 sites in 5 countries: 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 and Benzoyl Peroxide in people with Acne Vulgaris, run by Galderma R&D at 62 sites in 5 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 4 inclusion and 6 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 62 sites in United States, Canada, Germany, Hungary, Poland. 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 11 Mar 2009). 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 on the Investigator's Global Assessment (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 NCT00421993, which also lists 1 linked publication.
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.