A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
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
1 other identifier
interventional
366
1 country
25
Brief Summary
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFebruary 20, 2012
February 1, 2012
1.2 years
April 23, 2008
February 16, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in the number of inflammatory lesions
12 weeks
Improvement from baseline in global severity
12 weeks
Secondary Outcomes (1)
Change from baseline in the number of non-inflammatory lesions
12 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of inflammatory and non-inflammatory lesions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Dermatology Research of Arkansas, PLLC
Little Rock, Arkansas, 72205, United States
RADY Children's Hospital - San Diego
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
FXM Research Corp.
Miami, Florida, 33175, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Skin Specialist, PC
Omaha, Nebraska, 68144, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Dermatology Associates of Rochester
Rochester, New York, 14623, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790, United States
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, 27599, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J & S Studies, Inc.
Bryan, Texas, 77802, United States
The Center for Skin Research
Houston, Texas, 77056, United States
South Valley Dermatology
West Jordan, Utah, 84088, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 25, 2008
Study Start
January 1, 2008
Primary Completion
March 1, 2009
Study Completion
September 1, 2009
Last Updated
February 20, 2012
Record last verified: 2012-02