Sarcoidosis
Conditions
Keywords
Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
Brief summary
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.
Detailed description
The study consists in comparing thalidomide to placebo in skin sarcoidosis. Patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. They are randomized and receive either thalidomide or placebo for 3 months. Then they are given Thalidomide for a 3-month open-label period.
Interventions
DRUGTHALIDOMIDE
THALIDOMIDE
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven skin sarcoidosis * Assessable target skin lesions
Exclusion criteria
* Rapidly evolving sarcoidosis * Patients necessitating a corticosteroid regimen of more than 15mg per day. * Women not willing to undertake a contraceptive method. * Neurologic impairment * Past treatment with Thalidomide * Renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of target skin lesions at 3 months. | during de study | Size of target skin lesions at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. | during the study | Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. |
Countries
France
Outcome results
None listed