SARCOTHAL. Thalidomide in Skin Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305552
• Other study ID #: P031008
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: April 29, 2011
• Start date: February 2005
• Est. completion date: November 2007

Study information

• Verified date: January 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• THALIDOMIDE
THALIDOMIDE

Locations

Country	Name	City	State
France	HOPITAL Saint Louis, Service de Dermatologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of target skin lesions at 3 months.	Size of target skin lesions at 3 months.	during de study	Yes
Secondary	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.	during the study	Yes