NCT00305552

SARCOTHAL. Thalidomide in Skin Sarcoidosis

Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	THALIDOMIDE	THALIDOMIDE

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-03-22
• Last updated: 2011-05-02

Locations

1 site across 1 country: France