search
Back to results

A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IDP-115
Vehicle
Vehicle
Sponsored by
Dow Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of facial rosacea
  • Presence of inflammatory lesions

Exclusion Criteria:

  • Dermatological conditions of the face that could interfere with clinical evaluations
  • Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Sites / Locations

  • Medical Affiliated Research Center, Inc.
  • Therapeutics Clinical Research
  • Solano Clinical Research
  • Cherry Creek Dermatology Research Inc.
  • FXM Research Corp.
  • MedaPhase Inc.
  • Henry Ford Medical Center
  • Academic Dermatology Associates
  • University Dermatology Consultants, Inc.
  • DermResearch, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

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 erythema

Full Information

First Posted
April 23, 2008
Last Updated
February 16, 2012
Sponsor
Dow Pharmaceutical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00667173
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
Official Title
A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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-115 in treating patients with rosacea.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IDP-115
Intervention Description
Topical application for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
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 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 erythema
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of facial rosacea Presence of inflammatory lesions Exclusion Criteria: Dermatological conditions of the face that could interfere with clinical evaluations Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption) Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Therapeutics Clinical Research
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
Cherry Creek Dermatology Research Inc.
City
Denver,
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
FXM Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
MedaPhase Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University Dermatology Consultants, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

We'll reach out to this number within 24 hrs