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

NCT ID: NCT00667173

Last Updated: 2012-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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

Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

IDP-115

Intervention Type DRUG

Topical application for 12 weeks

2

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical application for 12 weeks

3

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical application for 12 weeks

Interventions

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IDP-115

Topical application for 12 weeks

Intervention Type DRUG

Vehicle

Topical application for 12 weeks

Intervention Type DRUG

Vehicle

Topical application for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow Pharmaceutical Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Solano Clinical Research

Vallejo, California, United States

Site Status

Cherry Creek Dermatology Research Inc.

Denver, Colorado, United States

Site Status

FXM Research Corp.

Miami, Florida, United States

Site Status

MedaPhase Inc.

Newnan, Georgia, United States

Site Status

Henry Ford Medical Center

Detroit, Michigan, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

University Dermatology Consultants, Inc.

Cincinnati, Ohio, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DPSI-IDP-115-P2-01

Identifier Type: -

Identifier Source: org_study_id

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