Acne VulgarisPhase 3NCT00599521
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
A Phase 3 study testing Adapalene lotion 0.1% in people with Acne Vulgaris, run by Galderma R&D at 34 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris. 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 lotion 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,067 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Nov 2007to Dec 2008
- 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
- Subjects with Moderate or Severe Acne Vulgaris,
- 20-50 papules and pustules in total on the face excluding the nose
- 30-100 non-inflammatory lesions on the face excluding the nose.
- Negative urine pregnancy test for all females.
Who cannot join
- Subjects with more than one acne nodule.
- Subjects with any acne cyst on the face.
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
- Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
- Subjects who are pregnant, nursing, or planning a pregnancy.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States29 sites
J&S Studies, Inc.
Bryan, Texas, 77802
Christie Clinic, PC
Champaign, Illinois, 61820
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University Dermatology Consultants
Cincinnati, Ohio, 45219
Midwest Cutaneous Research
Clinton Township, Michigan, 48038
Cherry Creek Dermatology
Denver, Colorado, 80246
Henry Ford Medical Center-Dept. of Dermatology
Detroit, Michigan, 48202
Minnesota Clinical Study Centert
Fridley, Minnesota, 55432
East Coast Clinical Research, Inc.
Haverhill, Massachusetts, 01830
The Center for Skin Research
Houston, Texas, 77056
Dermatology Associates
Knoxville, Tennessee, 37917
Dermatology Specialists
Louisville, Kentucky, 40202
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Dermatology Research Associates
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Fran Cook-Bolden
New York, New York, 10021
Central Sooner Research
Norman, Oklahoma, 73069
Compliant Clinical Research
Olathe, Kansas, 66061
Skin Specialists, PC
Omaha, Nebraska, 68144
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, 32174
Dermatology Research
Pinellas Park, Florida, 33781
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Cindy Lamerson
Reno, Nevada, 89511
Dermatology Associates of Rochester
Rochester, New York, 14623
Dermatology Research Center
Salt Lake City, Utah, 84124
University of California
San Diego, California, 92123
Premier Clinical Research
Spokane, Washington, 99204
Dermatology Specialists, Inc.
Vista, California, 92083
Canada5 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Dermatology Associates
Calgary, Alberta, T3A 2N1
Siena Medical Research
Montreal, Quebec, H3G 1C6
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Derm Research @ 888 Inc
Vancouver, British Columbia, V5Z 3Y1
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Read the detailed description
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene lotion 0.1%, Adapalene Lotion Vehicle
- Keywords
- Acne Vulgaris, Adapalene
- 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 lotion 0.1%Drug
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Adapalene Lotion VehicleDrug
Vehicle will be applied topically to the face, once a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adapalene lotion 0.1% | Experimental | Not described Receives: Drug: Adapalene lotion 0.1% |
| Adapalene Lotion vehicle | Placebo comparator | Not described Receives: Drug: Adapalene Lotion Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Measured: From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Measured: Baseline to 12 weeks
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Measured: Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Measured: Baseline to Week 12
Secondary outcomes (1)
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Percent change in lesion count from baseline to week 12
Measured: From Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionDec 2008
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 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
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599521
- Sponsor's protocol ID
- RD.06.SPR.18114
- Other IDs
- IND 076057
- Status last verified
- Mar 2011
- First submitted
- 11 Jan 2008
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00599521
- Acronym / sponsor ID
- RD.06.SPR.18114
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Adapalene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Posted 19 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Detailed description
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
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 |
|---|---|---|
| Adapalene lotion 0.1% | Experimental | Drug: Adapalene lotion 0.1% |
| Adapalene Lotion vehicle | Placebo comparator | Drug: Adapalene Lotion 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)
- Subjects with Moderate or Severe Acne Vulgaris,
- 20-50 papules and pustules in total on the face excluding the nose
- 30-100 non-inflammatory lesions on the face excluding the nose.
- Negative urine pregnancy test for all females.
Key exclusion criteria (5 listed)
- Subjects with more than one acne nodule.
- Subjects with any acne cyst on the face.
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
- Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
- Subjects who are pregnant, nursing, or planning a pregnancy.
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 lotion 0.1%Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks | Drug | Adapalene lotion 0.1% |
| Adapalene Lotion VehicleVehicle will be applied topically to the face, once a day, for 12 weeks | Drug | Adapalene Lotion vehicle |
Primary outcome
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Time frame: From Baseline to Week 12
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time frame: Baseline to 12 weeks
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time frame: Baseline to Week 12
1 secondary outcome
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Time frame: From Baseline to 12 weeks
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene lotion 0.1% in people with Acne Vulgaris, run by Galderma R&D at 34 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 4 inclusion and 5 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 34 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 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 19 Apr 2011). 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?
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 (time frame: From Baseline to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.