Phase 3 Papulopustular Rosacea Study

Galderma R&D683 enrolled

Overview

The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

683

Conditions

Papulopustular Rosacea (PPR)

Interventions

CD5024DRUG

CD5024 1% Cream, once daily

Azelaic acid 15% GelDRUG

Topical Gel applied twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe), 2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. Exclusion Criteria: 1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne, 2. The subject has rosacea with more than two nodules on the face.

Locations (50)

Outcomes

Primary Outcomes

Success Rate

Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)

Time frame: Week 12

Absolute Change in Inflammatory Lesion Count

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).

Time frame: Baseline to Week 12

Secondary Outcomes

Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UAB Dermatology Clinical Research

Birmingham, Alabama, United States

Northwest AR Clinical Trials Center

Rogers, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

University Clinical Trials

San Diego, California, United States

Research Across America

Santa Ana, California, United States

Cherry Creek Research, Inc.

Denver, Colorado, United States

The Center for Clinical & Cosmetic Research

Aventura, Florida, United States

The Dermatology and Aesthetic Center

Boca Raton, Florida, United States

North Florida Dermatology Associates

Jacksonville, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

...and 40 more locations