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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
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
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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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