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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00664248
Other study ID # DPSI-06-22-2006-012
Secondary ID
Status Completed
Phase Phase 3
First received April 15, 2008
Last updated April 18, 2008
Start date October 2006

Study information

Verified date April 2008
Source Dow Pharmaceutical Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.


Recruitment information / eligibility

Status Completed
Enrollment 1414
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 70 Years
Eligibility Inclusion Criteria:

- Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

- Dermatological conditions of the face other than acne that could interfere with clinical evaluations

- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
IDP-110
Topical application for 12 weeks
Clindamycin
Topical application for 12 weeks
Benzoyl peroxide
Topical application for 12 weeks
Vehicle
Topical application for 12 weeks

Locations

Country Name City State
Belize Dermatology and Skin Surgery Centre Belize City
Canada Mediprobe Research New London Ontario
United States Academic Dermatology Albuquerque New Mexico
United States Total Skin and Beauty Dermatology Center Birmingham Alabama
United States University of Alabama, Birmingham Birmingham Alabama
United States Office of Scott Glazer, MD Buffalo Grove Illinois
United States Triangle Medical Research Associates Cary North Carolina
United States Cherry Creek Dermatology Research Inc. Denver Colorado
United States Henry Ford Medical Center Detroit Michigan
United States Rivergate Dermatology Goodlettsville Tennessee
United States Unifour Medical Research Associates Hickory North Carolina
United States The Center for Skin Research Houston Texas
United States Medical Affiliated Research Center, Inc. Huntsville Alabama
United States Dermatology Associates Knoxville Tennessee
United States Dermatology Research of Arkansas Little Rock Arkansas
United States Longmont Medical Research Network Longmont Colorado
United States FXM Research Miami Florida
United States International Dermatology Research, Inc. Miami Florida
United States Advanced Healthcare Milwaukee Wisconsin
United States Dermatology Research Associates Nashville Tennessee
United States Tennessee Clinical Research Center Nashville Tennessee
United States Northwest Cutaneous Research Specialists Portland Oregon
United States Oregon Medical Center, PC Portland Oregon
United States Wake Research Associates, LLC Raleigh North Carolina
United States The Nevada Center for Dermatology Reno Nevada
United States Dermatology Resarch Center Salt Lake City Utah
United States Progressive Clinical Research San Antonio Texas
United States Affiliated Research Institute - Dermatology San Diego California
United States Therapeutics Clinical Research San Diego California
United States University of California, San Diego, Pediatric and Adolescent Dermatology San Diego California
United States Solano Clinical Research Vallejo California
United States Dermatology Specialists, Inc. Vista California
United States Advanced Clinical Research - Jordan Valley West Jordan Utah
United States Clinical Research Specialists West Santa Monica California
United States New Haven Medical Research Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Dow Pharmaceutical Sciences

Countries where clinical trial is conducted

United States,  Belize,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in number of lesions 12 weeks No
Secondary Change from baseline in global severity 12 weeks No
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