Back to resultsSARCOTHAL. Thalidomide in Skin Sarcoidosis
Primary Purpose
Sarcoidosis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
THALIDOMIDE
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
Eligibility 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
Sites / Locations
- HOPITAL Saint Louis, Service de Dermatologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
THALIDOMIDE
Outcomes
Primary Outcome Measures
Size of target skin lesions at 3 months.
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.
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Full Information
NCT ID
NCT00305552
First Posted
March 21, 2006
Last Updated
April 29, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00305552
Brief Title
SARCOTHAL. Thalidomide in Skin Sarcoidosis
Official Title
Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
THALIDOMIDE
Intervention Type
Drug
Intervention Name(s)
THALIDOMIDE
Intervention Description
THALIDOMIDE
Primary Outcome Measure Information:
Title
Size of target skin lesions at 3 months.
Description
Size of target skin lesions at 3 months.
Time Frame
during de study
Secondary Outcome Measure Information:
Title
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Description
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel RYBOJAD, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL Saint Louis, Service de Dermatologie
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24945194
Citation
Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015.
Results Reference
derived
Learn more about this trial
SARCOTHAL. Thalidomide in Skin Sarcoidosis
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