Clinical trial NCT00664248: A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 1414
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in number of lesions
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in global severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: San Diego
country: United States
facility: Affiliated Research Institute - Dermatology
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego, Pediatric and Adolescent Dermatology
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Vista
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: West Santa Monica
country: United States
facility: Clinical Research Specialists
state: California
city: Denver
country: United States
facility: Cherry Creek Dermatology Research Inc.
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Buffalo Grove
country: United States
facility: Office of Scott Glazer, MD
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Reno
country: United States
facility: The Nevada Center for Dermatology
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology
state: New Mexico
city: Cary
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: New Haven Medical Research
state: North Carolina
city: Portland
country: United States
facility: Northwest Cutaneous Research Specialists
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Center, PC
state: Oregon
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Resarch Center
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research - Jordan Valley
state: Utah
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
city: Belize City
country: Belize
facility: Dermatology and Skin Surgery Centre
city: New London
country: Canada
facility: Mediprobe Research
state: Ontario
Study officials:
References: