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Completed

NCT Number: NCT00305552

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

HOPITAL Saint Louis, Service de Dermatologie

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thalidomide

Drug

THALIDOMIDE

Primary outcomes

  1. Size of target skin lesions at 3 months.

    Time frame: during de study

    Size of target skin lesions at 3 months.

Secondary outcomes

  1. Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.

    Time frame: during the study

    Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 22, 2006
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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