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

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194375
• Other study ID #: DPSI-IDP-107-P2-02
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2010
• Last updated: June 20, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Presence of acne vulgaris on the face and neck/trunk

• Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

• Presence of any skin condition on the face that could interfere with clinical evaluations

• Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit

• Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit

• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

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 16 weeks
• High Strength IDP-107
Once a day for 16 weeks
• Placebo
Once a day for 16 weeks

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	The Centre for Dermatology and Cosmetic Surgery	Richmond Hill	Ontario
Canada	K. Papp Clinical Research	Waterloo	Ontario
United States	DermResearch, Inc.	Austin	Texas
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	ActivMed Practices and Research, Inc.	Haverhill	Massachusetts
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	FXM Research Corp.	Miami	Florida
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Ameriderm Research	Ormond Beach	Florida
United States	Pedia Research LLC	Owensboro	Kentucky
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Premier Clinical Research	Spokane	Washington
United States	South Valley Dermatology	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Dow Pharmaceutical Sciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of inflammatory lesions		Baseline and 22 weeks	No
Primary	Percent of patients who achieve success for the acne global severity score		Baseline and 22 weeks	No
Secondary	Change from baseline in the number of non-inflammatory lesions		Baseline and 22 weeks	No