- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00305552
SARCOTHAL. Thalidomide in Skin Sarcoidosis
April 29, 2011 updated by: Assistance Publique - Hôpitaux de Paris
Randomized Controlled Trial of Thalidomide vs Placebo 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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75010
- HOPITAL Saint Louis, Service de Dermatologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
THALIDOMIDE
|
THALIDOMIDE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Size of target skin lesions at 3 months.
Time Frame: during de study
|
Size of target skin lesions at 3 months.
|
during de study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michel RYBOJAD, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
March 21, 2006
First Submitted That Met QC Criteria
March 21, 2006
First Posted (Estimate)
March 22, 2006
Study Record Updates
Last Update Posted (Estimate)
May 2, 2011
Last Update Submitted That Met QC Criteria
April 29, 2011
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Sarcoidosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- P031008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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