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: NCT00598832
• Other study ID #: RD.06.SPR.18113
• Secondary ID: IND 076057
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Est. completion date: November 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: 1075
• Est. completion date: November 2008
• Est. primary completion date: October 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
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

Locations

Country	Name	City	State
Canada	The Dermatology Centre	Calgary	Alberta
Canada	Stratica Medical	Edmonton	Alberta
Canada	Lynderm Research, Inc.	Markham	Ontario
Canada	Nexus Clinical Research	St. Johns	Newfoundland and Labrador
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	K. Papp Clinical Research, Inc.	Waterloo	Ontario
Canada	Dermadvance Research	Winnipeg	Manitoba
United States	Academic Dermatology	Albuquerque	New Mexico
United States	Anne M. Loebl	Augusta	Georgia
United States	DermResearch, Inc.	Austin	Texas
United States	Scott Glazer	Buffalo Grove	Illinois
United States	Advanced Dermatology	Clermont	Florida
United States	Colorado Medical Research Center	Denver	Colorado
United States	Rivergate Dermatology	Goodlettsville	Tennessee
United States	Unifour Medical Research Associates	Hickory	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies	Houston	Texas
United States	Darmouth-Hitchcock Medical Center Section of Dermatology	Lebanon	New Hampshire
United States	Scott Dinehart	Little Rock	Arkansas
United States	Longmont Clinic	Longmont	Colorado
United States	Dermatology and Laser Center	Marina Del Rey	California
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	OU Health Sciences Center-Dept. of Dermatology	Oklahoma City	Oklahoma
United States	Hamzavi Dermatology	Port Huron	Michigan
United States	Oregon Medical Center, PC	Portland	Oregon
United States	Elizabeth Arthur	Rochester	New York
United States	Central Dermatology, PC	Saint Louis	Missouri
United States	Progressive Clinical Research	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Sound Bend Clinic	South Bend	Indiana
United States	Haber Dermatology & Cosmetic Research	South Euclid	Ohio
United States	Derm Research Center of New York	Stony Brook	New York
United States	Solano Clinical Research	Vallejo	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 Count From Baseline to Week 12		Baseline to Week 12
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 Week 12