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

NCT ID: NCT00599521

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1067 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Adapalene lotion 0.1%

Group Type: EXPERIMENTAL

Adapalene lotion 0.1%

Intervention Type: DRUG

Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks

Adapalene Lotion vehicle

Group Type: PLACEBO_COMPARATOR

Adapalene Lotion Vehicle

Intervention Type: DRUG

Vehicle will be applied topically to the face, once a day, for 12 weeks

Interventions

Adapalene lotion 0.1%

Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks

Intervention Type: DRUG

Adapalene Lotion Vehicle

Vehicle will be applied topically to the face, once a day, for 12 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Galderma Laboratories, Inc

Locations

University of California

San Diego, California, United States

Dermatology Specialists, Inc.

Vista, California, United States

Cherry Creek Dermatology

Denver, Colorado, United States

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, United States

Dermatology Research

Pinellas Park, Florida, United States

Christie Clinic, PC

Champaign, Illinois, United States

Compliant Clinical Research

Olathe, Kansas, United States

Dermatology Specialists

Louisville, Kentucky, United States

East Coast Clinical Research, Inc.

Haverhill, Massachusetts, United States

Midwest Cutaneous Research

Clinton Township, Michigan, United States

Henry Ford Medical Center-Dept. of Dermatology

Detroit, Michigan, United States

Minnesota Clinical Study Centert

Fridley, Minnesota, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Cindy Lamerson

Reno, Nevada, United States

Fran Cook-Bolden

New York, New York, United States

Dermatology Associates of Rochester

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

University Dermatology Consultants

Cincinnati, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Northwest Cutaneous Research Specialists

Portland, Oregon, United States

Palmetto Medical Research

Mt. Pleasant, South Carolina, United States

Dermatology Associates

Knoxville, Tennessee, United States

Dermatology Research Associates

Nashville, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

J&S Studies, Inc.

Bryan, Texas, United States

The Center for Skin Research

Houston, Texas, United States

Dermatology Research Center

Salt Lake City, Utah, United States

Premier Clinical Research

Spokane, Washington, United States

Dermatology Associates

Calgary, Alberta, Canada

Derm Research @ 888 Inc

Vancouver, British Columbia, Canada

Ultranova Skincare

Barrie, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

Siena Medical Research

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

IND 076057

Identifier Type: -

Identifier Source: secondary_id

RD.06.SPR.18114

Identifier Type: -

Identifier Source: org_study_id