Double blind, placebo controlled study Tacrolimus versus Emmolient in localized scleroderma

Double blind, placebo controlled study Tacrolimus versus Emmolient in localized scleroderma - tacrolimus

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31329

Enrollment

Registered

2007-09-03

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

localized scleroderma morphoea

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Nvt	—

Countries

Netherlands

Outcome results