Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
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
2 other identifiers
interventional
1,075
2 countries
34
Brief Summary
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2007
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedFebruary 18, 2021
March 1, 2011
11 months
January 11, 2008
April 16, 2010
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Baseline to Week 12
Secondary Outcomes (1)
Mean Percent Change in Total Lesion Count From Baseline to Week 12
From Baseline to Week 12
Study Arms (2)
Adapalene lotion 0.1%
EXPERIMENTALAdapalene Lotion vehicle
PLACEBO COMPARATORInterventions
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Eligibility Criteria
You may qualify if:
- Subjects with Moderate or Severe Acne Vulgaris,
- papules and pustules in total on the face excluding the nose
- non-inflammatory lesions on the face excluding the nose.
- Negative urine pregnancy test for all females.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (34)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Scott Dinehart
Little Rock, Arkansas, 72205, United States
Dermatology and Laser Center
Marina del Rey, California, 90292, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Longmont Clinic
Longmont, Colorado, 80501, United States
Advanced Dermatology
Clermont, Florida, 34711, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Anne M. Loebl
Augusta, Georgia, 30904, United States
Scott Glazer
Buffalo Grove, Illinois, 60089, United States
Sound Bend Clinic
South Bend, Indiana, 46617, United States
Hamzavi Dermatology
Port Huron, Michigan, 48060, United States
Central Dermatology, PC
St Louis, Missouri, 63117, United States
Darmouth-Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, 03756, United States
Academic Dermatology
Albuquerque, New Mexico, 87106, United States
Elizabeth Arthur
Rochester, New York, 14609, United States
Derm Research Center of New York
Stony Brook, New York, 11790, United States
Unifour Medical Research Associates
Hickory, North Carolina, 28601, United States
Haber Dermatology & Cosmetic Research
South Euclid, Ohio, 44118, United States
OU Health Sciences Center-Dept. of Dermatology
Oklahoma City, Oklahoma, 73104, United States
Oregon Medical Center, PC
Portland, Oregon, 97223, United States
Rivergate Dermatology
Goodlettsville, Tennessee, 37072, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Center for Clinical Studies
Houston, Texas, 77058, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
The Dermatology Centre
Calgary, Alberta, T2S 3B3, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, T3A2N1, Canada
Dermadvance Research
Winnipeg, Manitoba, R3C 1R4, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1B 3E1, Canada
Lynderm Research, Inc.
Markham, Ontario, L3P 6L2, Canada
K. Papp Clinical Research, Inc.
Waterloo, Ontario, N2J 1C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Graeber MD/ Head of Global Clinical Project Management
- Organization
- Galderma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 23, 2008
Study Start
November 1, 2007
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
February 18, 2021
Results First Posted
April 19, 2011
Record last verified: 2011-03