PATIENTS WITH PAPULOPUSTULAR ROSACEA MedDRA version: 9.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Sponsors
GALDERMA R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is a male or female 18 years of age or older, - The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe), - The subject has at least 15 and no more than 70 inflammatory lesions (papules and pustules) on the face, - Females of childbearing potential (including pre-menopausal subjects) with a negative urine pregnancy test (UPT) or females of non-childbearing potential, defined as post menopausal (absence of menstrual bleeding for one year prior to Screening visit), hysterectomy or bilateral oophorectomy. 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
Exclusion criteria
Exclusion criteria: - The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, - The subject has an underlying known disease, a surgical or medical condition, which in the judgment of the investigator, would put the subject at risk (e.g., uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, severe cardiopathy), or might confound the study assessments (e.g. other dermatological diseases), or might interfere with the subject’s participation in the study, (e.g. planned hospitalization during the study), - The subject has a beard or facial hair which would interfere with the study treatment and study assessment, - The subject is a lactating female, - The subject is a female who intends to conceive a child within 13 months following Baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to document the long-term safety of CD5024 1% cream once daily, in the topical treatment of papulopustular rosacea (PPR) for up to 52 weeks. ;Secondary Objective: The long term efficacy of CD5024 1% cream once daily will also be evaluated. Additionally CD5024 plasma levels monitoring will be used to assess a potential gradual increase in the plasmatic steady state concentrations throughout a long treatment period.;Primary end point(s): Safety assessment | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Iceland
Outcome results
None listed