EFFECT OF CD08514 VERSUS PLACEBO, IN PATIENTS PRESENTING WITH TYPE 1 ROSACEA, OVER AN 8-WEEK TREATMENT

Galderma R&D SNC0 sitesStarted: October 9, 2009Last updated: December 10, 2012

Conditions

Drugs

Trial Snapshot

No summary available.

•- 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.

Sponsor

Galderma R&D SNC