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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Low Strength IDP-107
High Strength IDP-107
Placebo
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 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

Sites / Locations

  • Dermatology Specialists, Inc.
  • Horizons Clinical Research Center, LLC
  • North Florida Dermatology Associates, PA
  • FXM Research Corp.
  • Ameriderm Research
  • Dawes Fretzin Clinical Research Group, LLC
  • The Indiana Clinical Trials Center, PC
  • Pedia Research LLC
  • ActivMed Practices and Research, Inc.
  • Hamzavi Dermatology
  • Minnesota Clinical Study Center
  • Comprehensive Clinical Research
  • Oregon Dermatology and Research Center
  • DermResearch, Inc.
  • Dermatology Research Center, Inc.
  • South Valley Dermatology
  • Premier Clinical Research
  • Ultranova Skincare
  • The Centre for Dermatology and Cosmetic Surgery
  • K. Papp Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Strength IDP-107

High Strength IDP-107

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the number of inflammatory lesions
Percent of patients who achieve success for the acne global severity score

Secondary Outcome Measures

Change from baseline in the number of non-inflammatory lesions

Full Information

First Posted
September 1, 2010
Last Updated
June 20, 2012
Sponsor
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01194375
Brief Title
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo 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
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Strength IDP-107
Arm Type
Experimental
Arm Title
High Strength IDP-107
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Low Strength IDP-107
Intervention Description
Once a day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
High Strength IDP-107
Intervention Description
Once a day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once a day for 16 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the number of inflammatory lesions
Time Frame
Baseline and 22 weeks
Title
Percent of patients who achieve success for the acne global severity score
Time Frame
Baseline and 22 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the number of non-inflammatory lesions
Time Frame
Baseline and 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dermatology Specialists, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
North Florida Dermatology Associates, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
FXM Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Pedia Research LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
ActivMed Practices and Research, Inc.
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
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
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
South Valley Dermatology
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
The Centre for Dermatology and Cosmetic Surgery
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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