Clinical trial NCT00663286: A Clinical Trial 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: 1399
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: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Hockessin
country: United States
facility: Webster Dermatology, PA
state: Delaware
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Clermont
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Pinellas Park
country: United States
facility: Dermatology Research
state: Florida
city: West Palm Beach
country: United States
facility: Florida Dermatology Institute
state: Florida
city: Augusta
country: United States
facility: Derm Center of Augusta
state: Georgia
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: Atlantic Dermatologic Associates, LLP
state: New York
city: New York
country: United States
facility: Office of Fran E. Cook-Bolden, MD
state: New York
city: Rochester
country: United States
facility: Helendale Dermatology and Medical Spa
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Carrollton
country: United States
facility: Thomas J. Stephens & Associates
state: Texas
city: Dallas
country: United States
facility: Dallas Associated Dermatologists
state: Texas
city: Lynchburg
country: United States
facility: Education & Research Foundation
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Madison
country: United States
facility: Madison Skin & Research, Inc.
state: Wisconsin
Study officials:
References: