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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adapalene lotion 0.1%
Adapalene Lotion Vehicle
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Adapalene

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California
  • Dermatology Specialists, Inc.
  • Cherry Creek Dermatology
  • Advanced Dermatology and Cosmetic Surgery
  • Dermatology Research
  • Christie Clinic, PC
  • Compliant Clinical Research
  • Dermatology Specialists
  • East Coast Clinical Research, Inc.
  • Midwest Cutaneous Research
  • Henry Ford Medical Center-Dept. of Dermatology
  • Minnesota Clinical Study Centert
  • Skin Specialists, PC
  • Cindy Lamerson
  • Fran Cook-Bolden
  • Dermatology Associates of Rochester
  • University of North Carolina at Chapel Hill
  • Wake Research Associates, LLC
  • University Dermatology Consultants
  • Central Sooner Research
  • Northwest Cutaneous Research Specialists
  • Palmetto Medical Research
  • Dermatology Associates
  • Dermatology Research Associates
  • Tennessee Clinical Research Center
  • J&S Studies, Inc.
  • The Center for Skin Research
  • Dermatology Research Center
  • Premier Clinical Research
  • Dermatology Associates
  • Derm Research @ 888 Inc
  • Ultranova Skincare
  • North Bay Dermatology Centre
  • Siena Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adapalene lotion 0.1%

Adapalene Lotion vehicle

Arm Description

Outcomes

Primary Outcome Measures

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.
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12

Secondary Outcome Measures

Mean Percent Change in Total Lesion Count From Baseline to Week 12
Percent change in lesion count from baseline to week 12

Full Information

First Posted
January 11, 2008
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00599521
Brief Title
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Adapalene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1067 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene lotion 0.1%
Arm Type
Experimental
Arm Title
Adapalene Lotion vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adapalene lotion 0.1%
Intervention Description
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene Lotion Vehicle
Intervention Description
Vehicle will be applied topically to the face, once a day, for 12 weeks
Primary Outcome Measure Information:
Title
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Description
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.
Time Frame
From Baseline to Week 12
Title
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time Frame
Baseline to 12 weeks
Title
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame
Baseline to Week 12
Title
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Description
Percent change in lesion count from baseline to week 12
Time Frame
From Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Dermatology Specialists, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Cherry Creek Dermatology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dermatology Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Christie Clinic, PC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Compliant Clinical Research
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
East Coast Clinical Research, Inc.
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Midwest Cutaneous Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Henry Ford Medical Center-Dept. of Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Centert
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Cindy Lamerson
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Fran Cook-Bolden
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University Dermatology Consultants
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Northwest Cutaneous Research Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Palmetto Medical Research
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Dermatology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
J&S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Dermatology Associates
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Derm Research @ 888 Inc
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Siena Medical Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1C6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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