Clinical trial NCT00666900: A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 366
Sex: ALL
Minimum age (years): 12
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 safety and effectiveness of IDP-107 in treating patients with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face 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 the number of inflammatory lesions
timeFrame: 12 weeks
measure: Improvement from baseline in global severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in the number of non-inflammatory lesions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas, PLLC
state: Arkansas
city: San Diego
country: United States
facility: RADY Children's Hospital - San Diego
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Miami
country: United States
facility: FXM Research Corp.
state: Florida
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialist, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals and School of Medicine
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: West Jordan
country: United States
facility: South Valley Dermatology
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Madison
country: United States
facility: Madison Skin & Research, Inc.
state: Wisconsin
Study officials:
References: