The primary objective of this study is to assess whether tacrolimus is effective for the treatment of morphea.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Initial assessment includes complete skin examination, durometerscore, a MSS
score, a histological investment of a representative sclerodermatous lesion (to
confirm the diagnose). Clinical features as dyspigmentation, induration,
atrofia, erythema and telangiectasia will be rated on a scale of 0 (none), 1
(mild), 2 (moderate) and 3 (severe). The lesions will also be photographed and
measured during each visit. Adverse reactions will be assessed. A histological
and a semi-quantitative (scale 0-6) clinical evaluation will be performed after
3 months.
Secondary outcome
Nvt
Background summary
Only case-reports showed that topical tacrolimus, an immunosuppressive
macrolide antibiotic, is effective and well tolerated in patients with
localized scleroderma.
However no double blind placebo controlled study is performed whether
tacrolimus is an effective treatment for morphea.
Tacrolimus is a immunomodulatory drug that act predominantly on T-cells.
Study objective
The primary objective of this study is to assess whether tacrolimus is
effective for the treatment of morphea.
Study design
All the patients with a localized scleroderma will be recruited from the
outpatients clinic from the Dermatology Department of the Radboud University
Hospital Nijmegen, the Netherlands.
20 patients will be selected with a localized scleroderma. This study will have
a 3 month follow up.
All the patients will be treated with an emolient and with tacrolimus 0.1%
(protopic®, Astellas) in a double blind selection on two selected
morpheaplaques. The ointment will be applied twice daily. Wash out time for
dermatocorticosteroids will be 3 weeks and for systemic immunosuppressives or
antifibrotic therapy 3 months.
Protopic (a steroid free ointment) is a registrated and common used therapy for
the treatment of eczema.
Study burden and risks
Protopic will be applied on small body surface. The side effects will be low.
No serious side effects are expected.
Tacrolimus is a registrated treatment for atopic dermatitis. The investigators
have enough experience with this topical treament.
Burden: patients have to come 3 times extra to the hospital. Each visit will
take approximately 20 minutes.
The studyparameters give minimal discomfort for the patient.
Rene Descartesdreef 1
6525 GL Nijmegen
Nederland
Rene Descartesdreef 1
6525 GL Nijmegen
Nederland
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004796-19-NL |
| CCMO | NL19464.091.07 |