SARCOTHAL. Thalidomide in Skin Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00305552
• Date of registration: 21/03/2006
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: SARCOTHAL. Thalidomide in Skin Sarcoidosis
• Scientific title: Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
• Date of first enrolment: February 2005
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00305552
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Michel RYBOJAD, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: THALIDOMIDE

Primary Outcome(s)

Size of target skin lesions at 3 months. [Time Frame: during de study]

Secondary Outcome(s)

Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. [Time Frame: during the study]

Secondary ID(s)

P031008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors