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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666900
• Other study ID #: DPSI-IDP-107-P2-01
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2008
• Last updated: February 16, 2012
• Start date: January 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2012
• Source: Dow Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Low Strength IDP-107
Once a day for 12 weeks
• High Strength IDP-107
Once a day for 12 weeks
• Placebo Comparator
Once a day for 12 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of inflammatory lesions		12 weeks	No
Primary	Improvement from baseline in global severity		12 weeks	No
Secondary	Change from baseline in the number of non-inflammatory lesions		12 weeks	No