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Trial record 1 of 3 for:    Thalidomide | sarcoidosis
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SARCOTHAL. Thalidomide in Skin Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305552
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : May 2, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: THALIDOMIDE Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
Study Start Date : February 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: 1

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305552

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HOPITAL Saint Louis, Service de Dermatologie
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Michel RYBOJAD, MD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Myriem CARRIER, Department Clinical Research of developpement Identifier: NCT00305552    
Other Study ID Numbers: P031008
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: January 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Randomized controlled trial
Thalidomide vs placebo
skin sarcoidosis
Additional relevant MeSH terms:
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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