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NCT00667173 Clinical Trial

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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00667173
Other study ID # DPSI-IDP-115-P2-01
Secondary ID
Status Completed
Phase Phase 2
First received April 23, 2008
Last updated February 16, 2012
Start date November 2007
Est. completion date July 2008

Study information
Verified date February 2012
Source Dow Pharmaceutical Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• IDP-115
Topical application for 12 weeks
• Vehicle
Topical application for 12 weeks
• Vehicle
Topical application for 12 weeks

Locations
Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States DermResearch, Inc. Austin Texas
United States University Dermatology Consultants, Inc. Cincinnati Ohio
United States Cherry Creek Dermatology Research Inc. Denver, Colorado
United States Henry Ford Medical Center Detroit Michigan
United States Medical Affiliated Research Center, Inc. Huntsville Alabama
United States FXM Research Corp. Miami Florida
United States MedaPhase Inc. Newnan Georgia
United States Therapeutics Clinical Research San Diego California
United States Solano Clinical Research Vallejo California

Sponsors (1)
Lead Sponsor Collaborator
Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the number of inflammatory lesions 12 weeks No
Primary Improvement from baseline in global severity 12 weeks No
Secondary Change from baseline in erythema 12 weeks No
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