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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Strength IDP-107
High Strength IDP-107
Placebo Comparator
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 - undefined (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 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
  • Dermatology Research of Arkansas, PLLC
  • RADY Children's Hospital - San Diego
  • Clinical Science Institute
  • Solano Clinical Research
  • Cherry Creek Research, Inc.
  • FXM Research Corp.
  • Michigan Center for Skin Care Research
  • Hamzavi Dermatology
  • Minnesota Clinical Study Center
  • Skin Specialist, PC
  • Academic Dermatology Associates
  • Dermatology Associates of Rochester
  • DermResearchCenter of New York, Inc.
  • University of North Carolina Hospitals and School of Medicine
  • University of Oklahoma Health Sciences Center
  • Oregon Dermatology and Research Center
  • Arlington Research Center, Inc.
  • DermResearch, Inc.
  • J & S Studies, Inc.
  • The Center for Skin Research
  • South Valley Dermatology
  • Virginia Clinical Research, Inc.
  • Premier Clinical Research
  • Madison Skin & Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the number of inflammatory lesions
Improvement from baseline in global severity

Secondary Outcome Measures

Change from baseline in the number of non-inflammatory lesions

Full Information

First Posted
April 23, 2008
Last Updated
February 16, 2012
Sponsor
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00666900
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow Pharmaceutical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and effectiveness of IDP-107 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Low Strength IDP-107
Intervention Description
Once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
High Strength IDP-107
Intervention Description
Once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Once a day for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the number of inflammatory lesions
Time Frame
12 weeks
Title
Improvement from baseline in global severity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the number of non-inflammatory lesions
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Dermatology Research of Arkansas, PLLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
RADY Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Cherry Creek Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
FXM Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Skin Specialist, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
DermResearchCenter of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
University of North Carolina Hospitals and School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
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
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
South Valley Dermatology
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
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

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

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