A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

Sponsor

Dow Pharmaceutical Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00663286

Collaborator

(none)

1,399

Enrollment

Locations

Arms

42.4

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-110 Drug: Clindamycin Drug: Benzoyl peroxide Drug: Vehicle	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1399 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: IDP-110 Topical application for 12 weeks
Active Comparator: 2	Drug: Clindamycin Topical application for 12 weeks
Active Comparator: 3	Drug: Benzoyl peroxide Topical application for 12 weeks
Placebo Comparator: 4	Drug: Vehicle Topical application for 12 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline in number of lesions [12 weeks]

Secondary Outcome Measures

Change from baseline in global severity [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

Dermatological conditions of the face other than acne that could interfere with clinical evaluations
Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
2	The Savin Center, PC	New Haven	Connecticut	United States	06511
3	Webster Dermatology, PA	Hockessin	Delaware	United States	19707
4	Skin Care Research, Inc.	Boca Raton	Florida	United States	33486
5	Advanced Dermatology and Cosmetic Surgery	Clermont	Florida	United States	34711
6	North Florida Dermatology Associates, PA	Jacksonville	Florida	United States	32204
7	Advanced Dermatology and Cosmetic Surgery	Ormond Beach	Florida	United States	32174
8	Dermatology Research	Pinellas Park	Florida	United States	33781
9	Florida Dermatology Institute	West Palm Beach	Florida	United States	33401
10	Derm Center of Augusta	Augusta	Georgia	United States	30904
11	MedaPhase Inc.	Newnan	Georgia	United States	30263
12	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia	United States	30078
13	DuPage Medical Group	Naperville	Illinois	United States	60563
14	Hudson Dermatology	Evansville	Indiana	United States	47714
15	South Bend Clinic	South Bend	Indiana	United States	46617
16	Dermatology Specialists Research	Louisville	Kentucky	United States	40202
17	Michigan Center for Research Corp.	Clinton Township	Michigan	United States	48038
18	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
19	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
20	Atlantic Dermatologic Associates, LLP	Brooklyn	New York	United States	11234
21	Office of Fran E. Cook-Bolden, MD	New York	New York	United States	10021
22	Helendale Dermatology and Medical Spa	Rochester	New York	United States	14609
23	Dermatology Associates of Rochester	Rochester	New York	United States	14623
24	DermResearch Center of New York	Stony Brook	New York	United States	11790
25	Central Sooner Research	Norman	Oklahoma	United States	73069
26	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
27	DermResearch, Inc.	Austin	Texas	United States	78759
28	J & S Studies, Inc.	Bryan	Texas	United States	77802
29	Thomas J. Stephens & Associates	Carrollton	Texas	United States	75006
30	Dallas Associated Dermatologists	Dallas	Texas	United States	75246
31	Education & Research Foundation	Lynchburg	Virginia	United States	24501
32	Virginia Clinical Research, Inc	Norfolk	Virginia	United States	23507
33	Madison Skin & Research, Inc.	Madison	Wisconsin	United States	53719