Phase 3 Papulopustular Rosacea Study

Galderma R&D688 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

688

Conditions

Papulopustular Rosacea

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

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Total Skin and Beauty

Birmingham, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Dermatology Specialists, Inc

Oceanside, California, United States

Integrated Research Group, Inc

Riverside, California, United States

Therapeutics Clinical Research

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

ATS Clinical Research

Santa Monica, California, United States

Redwood Dermatology Research

Santa Rosa, California, United States

FXM Research Corp Miami

Miami, Florida, United States

...and 40 more locations