Double blind, placebo controlled study Tacrolimus versus Emmolient in localized scleroderma
Phase 2
- Conditions
- localized sclerodermamorphoea10010761
- Registration Number
- NL-OMON31329
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Adults (aged ³ 18 years)
Patients must have a clinical diagnose of active morphea
Patients must have stopped systemic immunosuppressives/antifibrotic agents 3 months before start of this study
Wash out time for local treatments (like dermatocorticosteroids) is 3 weeks
Exclusion Criteria
Prooved adverse reactions of protopic (tacrolimus) in the past (hypersensitivity/intolerance)
Females who are pregnant or nursing or planning to become pregnant
Recent treatment with (dermato) corticosteroids or other antifibrotic therapy
Active skin infection at the morpheaplaque
Recent vaccination (from 14 days before start of this study)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Initial assessment includes complete skin examination, durometerscore, a MSS<br /><br>score, a histological investment of a representative sclerodermatous lesion (to<br /><br>confirm the diagnose). Clinical features as dyspigmentation, induration,<br /><br>atrofia, erythema and telangiectasia will be rated on a scale of 0 (none), 1<br /><br>(mild), 2 (moderate) and 3 (severe). The lesions will also be photographed and<br /><br>measured during each visit. Adverse reactions will be assessed. A histological<br /><br>and a semi-quantitative (scale 0-6) clinical evaluation will be performed after<br /><br>3 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Nvt</p><br>