EFFECT OF CD08514 VERSUS PLACEBO, IN PATIENTS PRESENTING WITH TYPE 1 ROSACEA, OVER AN 8-WEEK TREATMENT
- Conditions
- Moderate to severe erythematotelangiectactic rosacea (ETR)MedDRA version: 12.0Level: LLTClassification code 10039218Term: Rosacea
- Registration Number
- EUCTR2009-013111-35-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 aged 18 to 65.
- Subject presenting with moderate to severe ETR characterized by:
* A persistent erythema on the face,
* An erythema severity score graded at least 3 on a 5-point scale (from 0 to 4), on each cheek,
* No history of inflammatory (papules and/or pustules) lesions during the past 3 months before Baseline. However, subject with a few papules and/or pustules on non-analysed areas could be included.
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) no
F.1.3.1 Number of subjects for this age range
- The subject has a particular form of rosacea or rosacea like syndrome (papulopustular rosacea, rhinophyma, severe forms: 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 with peri-oral dermatitis.
- The subject has an underlying disease, surgical or medical condition, which:
* could interfere with evaluations of the rosacea condition itself (e.g., atopic dermatitis, eczema or acne vulgaris);
* could put the subject at risk (uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS…).
- The subject has a past history of gastric or duodenal ulcer, gastrooesophageal reflux disease (GERD), oesophagitis or pathological hypersecretory conditions or a Zollinger-Ellison syndrome or recurrent gastralgies.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of CD08514 40 mg and 10 mg BID (i.e. respectively 80 mg and 20 mg per day) over 8 weeks of treatment, in a double blind placebo-controlled study, in subjects presenting with moderate to severe erythematotelangiectatic rosacea (ETR). ;Secondary Objective: To evaluate the safety profile of CD08514 40 mg and 10 mg BID (i.e. respectively 80 mg and 20 mg per day) over 8 weeks of treatment, in a double blind placebo-controlled study, in subjects presenting with moderate to severe ETR.;Primary end point(s): Change from baseline in cheek-combined erythema severity score (total sum score of the 2 cheeks) on Day 54
- Secondary Outcome Measures
Name Time Method