SARCOTHAL. Thalidomide in Skin Sarcoidosis

Phase 3

Completed

• Conditions: Sarcoidosis
• Interventions: Drug: THALIDOMIDE

• Registration Number: NCT00305552
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Status Verified: 2007-01
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	THALIDOMIDE	THALIDOMIDE

Primary Outcome Measures

Name	Time	Method
Size of target skin lesions at 3 months.	during de study	Size of target skin lesions at 3 months.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

HOPITAL Saint Louis, Service de Dermatologie; 🇫🇷 Paris, France