A DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE ACTIVITY OF CD5024 1% CREAM IN SUBJECTS WITH PAPULOPUSTULAR ROSACEA OVER 12 WEEKS TREATMENT

• Conditions: PATIENTS WITH PAPULOPUSTULAR ROSACEA; MedDRA version: 9.1Level: LLTClassification code 10039218Term: Rosacea

• Registration Number: EUCTR2010-018319-13-DE
• Lead Sponsor: GALDERMA R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-01
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

1. The subject is a male or female 18 years of age or older.

2. The subject has papulopustular rosacea, with an Investigator Global Assessment (IGA), score rated = 3.

3. The subject has at least 15 inflammatory lesions (papules and pustules) on the face.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis.

2. The subject has ocular rosacea requiring either a systemic treatment or an interfering treatment.

3. The subject has an underlying known disease, a surgical or medical condition, which in the judgment of the investigator, would put the subject at risk, or might confound the study assessments, or might interfere with the subject’s participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified