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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599521
• Other study ID #: RD.06.SPR.18114
• Secondary ID: IND 076057
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2011
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1067
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
• Adapalene Lotion Vehicle
Vehicle will be applied topically to the face, once a day, for 12 weeks

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Dermatology Associates	Calgary	Alberta
Canada	Siena Medical Research	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Derm Research @ 888 Inc	Vancouver	British Columbia
United States	J&S Studies, Inc.	Bryan	Texas
United States	Christie Clinic, PC	Champaign	Illinois
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University Dermatology Consultants	Cincinnati	Ohio
United States	Midwest Cutaneous Research	Clinton Township	Michigan
United States	Cherry Creek Dermatology	Denver	Colorado
United States	Henry Ford Medical Center-Dept. of Dermatology	Detroit	Michigan
United States	Minnesota Clinical Study Centert	Fridley	Minnesota
United States	East Coast Clinical Research, Inc.	Haverhill	Massachusetts
United States	The Center for Skin Research	Houston	Texas
United States	Dermatology Associates	Knoxville	Tennessee
United States	Dermatology Specialists	Louisville	Kentucky
United States	Palmetto Medical Research	Mount Pleasant	South Carolina
United States	Dermatology Research Associates	Nashville	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Fran Cook-Bolden	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Compliant Clinical Research	Olathe	Kansas
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Advanced Dermatology and Cosmetic Surgery	Ormond Beach	Florida
United States	Dermatology Research	Pinellas Park	Florida
United States	Northwest Cutaneous Research Specialists	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Cindy Lamerson	Reno	Nevada
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Dermatology Research Center	Salt Lake City	Utah
United States	University of California	San Diego	California
United States	Premier Clinical Research	Spokane	Washington
United States	Dermatology Specialists, Inc.	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12		Baseline to 12 weeks
Primary	Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12		Baseline to Week 12
Primary	Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12		Baseline to Week 12
Secondary	Mean Percent Change in Total Lesion Count From Baseline to Week 12	Percent change in lesion count from baseline to week 12	From Baseline to 12 weeks