SARCOTHAL. Thalidomide in Skin Sarcoidosis

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Sarcoidosis

Treatments: Drug: THALIDOMIDE

Study type: Interventional

Funder types: Other

Identifiers

NCT00305552

P031008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 1 patient group

1

Experimental group

Description:

THALIDOMIDE

Treatment:

Drug: THALIDOMIDE