Effect of CD07805/47 gel in rosacea flushing

• Conditions: Flushing related to erythematotelangiectatic or papulopustular rosacea; MedDRA version: 16.1Level: PTClassification code 10016825Term: FlushingSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-005083-26-DE
• Lead Sponsor: Galderma R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-11
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The subject is a male or female, who is at least 18 years of age or older at Screening visit.

2. The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea (ETR) or mild to moderate papulo-pustular rosacea (PPR) according to the National Rosacea Society grading (Wilkin et al., 2004).

3. The subject had at least five flushing episodes during the last week before 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 36
F.1.3 Elderly (>=65 years) no
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 concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia;

2. The subject has current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;

3.The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;

Study & Design

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