CD5024 1% cream versus metronidazole 0.75% cream in papulopustular rosacea (PPR) study

• Conditions: Papulo Pustular Rosacea; MedDRA version: 14.1Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-004791-11-CZ
• Lead Sponsor: Galderma R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-10
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

- Male or female subjects 18 years of age or older at the Screening Visit,

- Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA) at Screening and Baseline visits,

- Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face at Screening and Baseline visits.
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 580

Exclusion Criteria

- Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, or seborrheic dermatitis and acne at Screening and Baseline visits,

- Subjects with rosacea with more than two nodules on the face at Screening and Baseline visits.

Study & Design

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