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SARCOTHAL. Thalidomide in Skin Sarcoidosis

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 21, 2006
Last updated: April 29, 2011
Last verified: January 2007
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.

Condition Intervention Phase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Size of target skin lesions at 3 months. [ Time Frame: during de study ]
    Size of target skin lesions at 3 months.

Secondary Outcome Measures:
  • 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.

Enrollment: 40
Study Start Date: February 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00305552

HOPITAL Saint Louis, Service de Dermatologie
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Michel RYBOJAD, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Myriem CARRIER, Department Clinical Research of developpement Identifier: NCT00305552     History of Changes
Other Study ID Numbers: P031008
Study First Received: March 21, 2006
Last Updated: April 29, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Randomized controlled trial
Thalidomide vs placebo
skin sarcoidosis

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 28, 2017