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

NCT00599521 | Completed Phase 3 Results

• 2 other identifiers: RD.06.SPR.18114IND 076057
• Study Type: interventional
• Target: 1,067
• Locations: 2 countries
• Sites: 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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Adapalene

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 Counts From Baseline to Week 12

  Baseline to 12 weeks

• 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 12 weeks

Study Arms (2)

Adapalene lotion 0.1%

EXPERIMENTAL

Drug: Adapalene lotion 0.1%

Adapalene Lotion vehicle

PLACEBO COMPARATOR

Drug: Adapalene Lotion Vehicle

Interventions

Adapalene lotion 0.1% DRUG

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

Adapalene lotion 0.1%

Adapalene Lotion Vehicle DRUG

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

Adapalene Lotion vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (34)

University of California

San Diego, California, 92123, United States

Location

Dermatology Specialists, Inc.

Vista, California, 92083, United States

Location

Cherry Creek Dermatology

Denver, Colorado, 80246, United States

Location

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, 32174, United States

Location

Dermatology Research

Pinellas Park, Florida, 33781, United States

Location

Christie Clinic, PC

Champaign, Illinois, 61820, United States

Location

Compliant Clinical Research

Olathe, Kansas, 66061, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

East Coast Clinical Research, Inc.

Haverhill, Massachusetts, 01830, United States

Location

Midwest Cutaneous Research

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Medical Center-Dept. of Dermatology

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Centert

Fridley, Minnesota, 55432, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Cindy Lamerson

Reno, Nevada, 89511, United States

Location

Fran Cook-Bolden

New York, New York, 10021, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

University Dermatology Consultants

Cincinnati, Ohio, 45219, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069, United States

Location

Northwest Cutaneous Research Specialists

Portland, Oregon, 97210, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Dermatology Associates

Knoxville, Tennessee, 37917, United States

Location

Dermatology Research Associates

Nashville, Tennessee, 37203, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

J&S Studies, Inc.

Bryan, Texas, 77802, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Dermatology Associates

Calgary, Alberta, T3A 2N1, Canada

Location

Derm Research @ 888 Inc

Vancouver, British Columbia, V5Z 3Y1, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Siena Medical Research

Montreal, Quebec, H3G 1C6, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Michael Graeber MD/ Head of Global Clinical Project Management
• Organization: Galderma

michael.graeber@galderma.com

609-860-8201

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: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2021
• Results First Posted: April 19, 2011

Record last verified: 2011-03

Locations

US (29); CA (5)