Effect of CD08100/02 3% gel versus placebo in subjects presenting with erythematotelangiectatic rosacea over a 4 week treatment period.
- Conditions
- Erythematotelangiectatic rosaceaMedDRA version: 14.0Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-002057-65-DE
- Lead Sponsor
- Galderma R&D SNC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- The subject is a male or female adult of at least 18 years old.
- The subject presents a moderate to severe ETR
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 25
- The subject has the following forms of rosacea or rosacea like syndrome: papulopustular rosacea, rosacea conglobata or fulminans, corticosteroids-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (known carcinoid syndrome, dysthyroidism, mastocytose, serotonin syndrome, lupus erythematosis) or peri-oral dermatitis;
- The subject has an underlying disease, surgical or medical condition, which, in the opinion of the investigator
• could interfere with evaluations of rosacea itself (e.g., atopic dermatitis, eczema, acne vulgaris);
• could put the subject at risk, such as uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial (such as cancer or AIDS);
- The subject has a known past history of hypersensitivity to diclofenac or any of the components of the study products
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of CD08100/02 3% gel versus placebo gel after a 4-week treatment period, in subjects presenting with moderate to severe ETR.<br><br><br><br>;Secondary Objective: To evaluate the safety of CD08100/02 3% gel by adverse events (AE) reporting, physical examination and vital signs.;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: At each evaluation visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: At each evaluation visit