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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IDP-110
Clindamycin
Benzoyl peroxide
Vehicle
Sponsored by
Dow Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Burke Pharmaceutical Research
  • The Savin Center, PC
  • Webster Dermatology, PA
  • Skin Care Research, Inc.
  • Advanced Dermatology and Cosmetic Surgery
  • North Florida Dermatology Associates, PA
  • Advanced Dermatology and Cosmetic Surgery
  • Dermatology Research
  • Florida Dermatology Institute
  • Derm Center of Augusta
  • MedaPhase Inc.
  • Gwinnett Clinical Research Center, Inc.
  • DuPage Medical Group
  • Hudson Dermatology
  • South Bend Clinic
  • Dermatology Specialists Research
  • Michigan Center for Research Corp.
  • Minnesota Clinical Study Center
  • SUNY Downstate Medical Center
  • Atlantic Dermatologic Associates, LLP
  • Office of Fran E. Cook-Bolden, MD
  • Helendale Dermatology and Medical Spa
  • Dermatology Associates of Rochester
  • DermResearch Center of New York
  • Central Sooner Research
  • Milton S. Hershey Medical Center
  • DermResearch, Inc.
  • J & S Studies, Inc.
  • Thomas J. Stephens & Associates
  • Dallas Associated Dermatologists
  • Education & Research Foundation
  • Virginia Clinical Research, Inc
  • Madison Skin & Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in number of lesions

Secondary Outcome Measures

Change from baseline in global severity

Full Information

First Posted
April 15, 2008
Last Updated
April 18, 2008
Sponsor
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00663286
Brief Title
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dow Pharmaceutical Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1399 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IDP-110
Intervention Description
Topical application for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
Topical application for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide
Intervention Description
Topical application for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical application for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in number of lesions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in global severity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Webster Dermatology, PA
City
Hockessin
State/Province
Delaware
ZIP/Postal Code
19707
Country
United States
Facility Name
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Surgery
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
North Florida Dermatology Associates, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dermatology Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Florida Dermatology Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Derm Center of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
MedaPhase Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Michigan Center for Research Corp.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Atlantic Dermatologic Associates, LLP
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Office of Fran E. Cook-Bolden, MD
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Helendale Dermatology and Medical Spa
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
DermResearch Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Thomas J. Stephens & Associates
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Dallas Associated Dermatologists
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Education & Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Madison Skin & Research, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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