SARCOTHAL. Thalidomide in Skin Sarcoidosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis|
- Size of target skin lesions at 3 months. [ Time Frame: during de study ] [ Designated as safety issue: Yes ]Size of target skin lesions at 3 months.
- Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
|Study Start Date:||February 2005|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Other Name: THALIDOMIDE
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.
|HOPITAL Saint Louis, Service de Dermatologie|
|Paris, France, 75010|
|Principal Investigator:||Michel RYBOJAD, MD||Assistance Publique - Hôpitaux de Paris|