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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
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

  • Total Skin and Beauty Dermatology Center
  • University of Alabama, Birmingham
  • Medical Affiliated Research Center, Inc.
  • Dermatology Research of Arkansas
  • Affiliated Research Institute - Dermatology
  • Therapeutics Clinical Research
  • University of California, San Diego, Pediatric and Adolescent Dermatology
  • Solano Clinical Research
  • Dermatology Specialists, Inc.
  • Clinical Research Specialists
  • Cherry Creek Dermatology Research Inc.
  • Longmont Medical Research Network
  • International Dermatology Research, Inc.
  • FXM Research
  • Office of Scott Glazer, MD
  • Henry Ford Medical Center
  • The Nevada Center for Dermatology
  • Academic Dermatology
  • Triangle Medical Research Associates
  • Unifour Medical Research Associates
  • Wake Research Associates, LLC
  • New Haven Medical Research
  • Northwest Cutaneous Research Specialists
  • Oregon Medical Center, PC
  • Rivergate Dermatology
  • Dermatology Associates
  • Dermatology Research Associates
  • Tennessee Clinical Research Center
  • The Center for Skin Research
  • Progressive Clinical Research
  • Dermatology Resarch Center
  • Advanced Clinical Research - Jordan Valley
  • Advanced Healthcare
  • Dermatology and Skin Surgery Centre
  • Mediprobe Research

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
NCT00664248
Brief Title
A Clinical Study 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
1414 (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
Total Skin and Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Dermatology Research of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Affiliated Research Institute - Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Diego, Pediatric and Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Dermatology Specialists, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Clinical Research Specialists
City
West Santa Monica
State/Province
California
ZIP/Postal Code
90404-2115
Country
United States
Facility Name
Cherry Creek Dermatology Research Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
FXM Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Office of Scott Glazer, MD
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
The Nevada Center for Dermatology
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Academic Dermatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Triangle Medical Research Associates
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Unifour Medical Research Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
New Haven Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Northwest Cutaneous Research Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Dermatology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Resarch Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Advanced Clinical Research - Jordan Valley
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Dermatology and Skin Surgery Centre
City
Belize City
Country
Belize
Facility Name
Mediprobe Research
City
New London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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