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

Phase 2CompletedNCT00667173

Dow Pharmaceutical Sciences140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Rosacea

Interventions

IDP-115DRUG

Topical application for 12 weeks

VehicleDRUG

Topical application for 12 weeks

VehicleDRUG

Topical application for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Therapeutics Clinical Research

San Diego, California, United States

Solano Clinical Research

Vallejo, California, United States

Outcomes

Primary Outcomes

Change from baseline in the number of inflammatory lesions

Time frame: 12 weeks

Improvement from baseline in global severity

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in erythema

Time frame: 12 weeks

Data from ClinicalTrials.gov

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