Moderate to severe erythematotelangiectactic rosacea (ETR) MedDRA version: 12.0 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Interventions
Trade Name: Famotidin-ratiopharm®
Product Name: Ratiopharm®
Product Code: CD08514
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMOTIDINE
CAS Number: 76824-35-6
Current Sponsor code: CD08514
Other
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed