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Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598832
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Information provided by:

Brief Summary:
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1075 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Experimental: Adapalene lotion 0.1% Drug: Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks

Placebo Comparator: Adapalene Lotion vehicle Drug: Adapalene Lotion Vehicle
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

Primary Outcome Measures :
  1. 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.

  2. Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  3. Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  4. Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
    Percent change in lesion count from baseline to week 12

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598832

Hide Hide 34 study locations
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United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Scott Dinehart
Little Rock, Arkansas, United States, 72205
United States, California
Dermatology and Laser Center
Marina Del Rey, California, United States, 90292
Therapeutics Clinical Research
San Diego, California, United States, 92123
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Colorado
Colorado Medical Research Center
Denver, Colorado, United States, 80210
Longmont Clinic
Longmont, Colorado, United States, 80501
United States, Florida
Advanced Dermatology
Clermont, Florida, United States, 34711
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Georgia
Anne M. Loebl
Augusta, Georgia, United States, 30904
United States, Illinois
Scott Glazer
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Sound Bend Clinic
South Bend, Indiana, United States, 46617
United States, Michigan
Hamzavi Dermatology
Port Huron, Michigan, United States, 48060
United States, Missouri
Central Dermatology, PC
St. Louis, Missouri, United States, 63117
United States, New Hampshire
Darmouth-Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
Academic Dermatology
Albuquerque, New Mexico, United States, 87106
United States, New York
Elizabeth Arthur
Rochester, New York, United States, 14609
Derm Research Center of New York
Stony Brook, New York, United States, 11790
United States, North Carolina
Unifour Medical Research Associates
Hickory, North Carolina, United States, 28601
United States, Ohio
Haber Dermatology & Cosmetic Research
South Euclid, Ohio, United States, 44118
United States, Oklahoma
OU Health Sciences Center-Dept. of Dermatology
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Medical Center, PC
Portland, Oregon, United States, 97223
United States, Tennessee
Rivergate Dermatology
Goodlettsville, Tennessee, United States, 37072
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Center for Clinical Studies
Houston, Texas, United States, 77058
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, Alberta
The Dermatology Centre
Calgary, Alberta, Canada, T2S 3B3
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, T3A2N1
Canada, Manitoba
Dermadvance Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Newfoundland and Labrador
Nexus Clinical Research
St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
Lynderm Research, Inc.
Markham, Ontario, Canada, L3P 6L2
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada, N2J 1C4
Sponsors and Collaborators
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Responsible Party: Marie Ciardella Clinical Administrator, Galderma Identifier: NCT00598832    
Other Study ID Numbers: RD.06.SPR.18113
IND 076057
First Posted: January 23, 2008    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011
Keywords provided by Galderma:
Acne Vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents