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SARCOTHAL. Thalidomide in Skin Sarcoidosis

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00305552
First received: March 21, 2006
Last updated: April 29, 2011
Last verified: January 2007
History of Changes
  Purpose

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
Sarcoidosis
 Drug: THALIDOMIDE
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Thalidomide
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
THALIDOMIDE
 Drug: THALIDOMIDE
THALIDOMIDE
Other Name: THALIDOMIDE

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Myriem CARRIER, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00305552     History of Changes
Other Study ID Numbers: P031008
Study First Received: March 21, 2006
Last Updated: April 29, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013