A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Low Strength IDP-107
Drug: High Strength IDP-107
Drug: Placebo Comparator

Registration Number: NCT00666900

Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary: The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 366

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low Strength IDP-107	-
2	High Strength IDP-107	-
3	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of inflammatory lesions	12 weeks
Improvement from baseline in global severity	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the number of non-inflammatory lesions	12 weeks

Trial Locations

Locations (25): Clinical Science Institute
🇺🇸
Santa Monica, California, United States
Solano Clinical Research
🇺🇸
Vallejo, California, United States
DermResearchCenter of New York, Inc.
🇺🇸
Stony Brook, New York, United States
Arlington Research Center, Inc.
🇺🇸
Arlington, Texas, United States
RADY Children's Hospital - San Diego
🇺🇸
San Diego, California, United States
J & S Studies, Inc.
🇺🇸
Bryan, Texas, United States
Cherry Creek Research, Inc.
🇺🇸
Denver, Colorado, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Michigan Center for Skin Care Research
🇺🇸
Clinton Township, Michigan, United States
Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States
Skin Specialist, PC
🇺🇸
Omaha, Nebraska, United States
Hamzavi Dermatology
🇺🇸
Fort Gratiot, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
University of North Carolina Hospitals and School of Medicine
🇺🇸
Chapel Hill, North Carolina, United States
DermResearch, Inc.
🇺🇸
Austin, Texas, United States
Dermatology Research of Arkansas, PLLC
🇺🇸
Little Rock, Arkansas, United States
FXM Research Corp.
🇺🇸
Miami, Florida, United States
The Center for Skin Research
🇺🇸
Houston, Texas, United States
Dermatology Associates of Rochester
🇺🇸
Rochester, New York, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
South Valley Dermatology
🇺🇸
West Jordan, Utah, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Madison Skin & Research, Inc.
🇺🇸
Madison, Wisconsin, United States