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-BG

Lead Sponsor: Galderma R&D SNC

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Period A:<br>To compare efficacy and safety of CD5024 1% cream applied once daily versus metronidazole 0.75% cream applied twice daily in subjects with papulopustular rosacea after 16-week topical treatment.<br>The study is powered to detect a 10 % superiority of CD5024 1% cream over metronidazole 0.75% cream determined by percent reduction of inflammatory lesions from Baseline.<br><br>Period B:<br>To compare, for subjects initially successfully treated by 16 weeks treatment, CD5024 1% cream versus metronidazole 0.75% cream during a 36-week extension period by assessing:<br>- The time of first relapse,<br>- The relapse rate,<br>- And the number of days free of treatment;Secondary Objective: Not applicable;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: From baseline to week 16

Secondary Outcome Measures