SARCOTHAL. Thalidomide in Skin Sarcoidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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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

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Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

THALIDOMIDE

Group Type EXPERIMENTAL

THALIDOMIDE

Intervention Type DRUG

THALIDOMIDE

Interventions

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THALIDOMIDE

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No