- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599521
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
February 16, 2021 updated by: Galderma R&D
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1067
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3A 2N1
- Dermatology Associates
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3Y1
- Derm Research @ 888 Inc
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Ontario
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Barrie, Ontario, Canada, L4M 6L2
- Ultranova Skincare
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North Bay, Ontario, Canada, P1B 3Z7
- North Bay Dermatology Centre
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Quebec
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Montreal, Quebec, Canada, H3G 1C6
- Siena Medical Research
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California
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San Diego, California, United States, 92123
- University of California
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Vista, California, United States, 92083
- Dermatology Specialists, Inc.
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Colorado
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Denver, Colorado, United States, 80246
- Cherry Creek Dermatology
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Florida
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Ormond Beach, Florida, United States, 32174
- Advanced Dermatology and Cosmetic Surgery
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Pinellas Park, Florida, United States, 33781
- Dermatology Research
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Illinois
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Champaign, Illinois, United States, 61820
- Christie Clinic, PC
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Kansas
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Olathe, Kansas, United States, 66061
- Compliant Clinical Research
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Kentucky
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Louisville, Kentucky, United States, 40202
- Dermatology Specialists
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Massachusetts
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Haverhill, Massachusetts, United States, 01830
- East Coast Clinical Research, Inc.
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Michigan
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Clinton Township, Michigan, United States, 48038
- Midwest Cutaneous Research
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Detroit, Michigan, United States, 48202
- Henry Ford Medical Center-Dept. of Dermatology
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Centert
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Nebraska
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Omaha, Nebraska, United States, 68144
- Skin Specialists, PC
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Nevada
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Reno, Nevada, United States, 89511
- Cindy Lamerson
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New York
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New York, New York, United States, 10021
- Fran Cook-Bolden
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Rochester, New York, United States, 14623
- Dermatology Associates of Rochester
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates, LLC
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Ohio
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Cincinnati, Ohio, United States, 45219
- University Dermatology Consultants
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Central Sooner Research
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Oregon
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Portland, Oregon, United States, 97210
- Northwest Cutaneous Research Specialists
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- Palmetto Medical Research
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Tennessee
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Knoxville, Tennessee, United States, 37917
- Dermatology Associates
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Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
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Nashville, Tennessee, United States, 37203
- Dermatology Research Associates
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Texas
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Bryan, Texas, United States, 77802
- J&S Studies, Inc.
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Houston, Texas, United States, 77056
- The Center for Skin Research
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Utah
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Salt Lake City, Utah, United States, 84124
- Dermatology Research Center
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Washington
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Spokane, Washington, United States, 99204
- Premier Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adapalene lotion 0.1%
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Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
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Placebo Comparator: Adapalene Lotion vehicle
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Vehicle will be applied topically to the face, once a day, for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Time Frame: From Baseline to Week 12
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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.
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From Baseline to Week 12
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Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
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Baseline to Week 12
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Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame: Baseline to Week 12
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Baseline to Week 12
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Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time Frame: Baseline to 12 weeks
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Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Time Frame: From Baseline to 12 weeks
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Percent change in lesion count from baseline to week 12
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From Baseline to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 23, 2008
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 16, 2021
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Dermatologic Agents
- Adapalene
Other Study ID Numbers
- RD.06.SPR.18114
- IND 076057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
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Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
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Assiut UniversityCompleted
-
Zagazig UniversityCompletedAcne Vulgaris Superficial Mixed Comedonal and InflammatoryEgypt
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-
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-
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