Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305552
Status:
COMPLETED
Last Update Posted:
2011-05-02
First Post:
2006-03-21
Brief Title:
SARCOTHAL Thalidomide in Skin Sarcoidosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None