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SARCOTHAL. Thalidomide in Skin Sarcoidosis

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ClinicalTrials.gov Identifier: NCT00305552
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
THALIDOMIDE
 Drug: THALIDOMIDE
THALIDOMIDE


Outcome Measures
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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.


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

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
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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 ClinicalTrials.gov identifier (NCT number): NCT00305552


Locations
France
HOPITAL Saint Louis, Service de Dermatologie
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Michel RYBOJAD, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Myriem CARRIER, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00305552     History of Changes
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
Thalidomide

Additional relevant MeSH terms:
Sarcoidosis
Thalidomide
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