SARCOTHAL. Thalidomide in Skin Sarcoidosis
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ClinicalTrials.gov Identifier: NCT00305552 |
Recruitment Status :
Completed
First Posted : March 22, 2006
Last Update Posted : May 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoidosis | Drug: THALIDOMIDE | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
THALIDOMIDE
|
Drug: THALIDOMIDE
THALIDOMIDE |
- Size of target skin lesions at 3 months. [ Time Frame: during de study ]Size of target skin lesions at 3 months.
- Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. [ Time Frame: during the study ]Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305552
France | |
HOPITAL Saint Louis, Service de Dermatologie | |
Paris, France, 75010 |
Principal Investigator: | Michel RYBOJAD, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Myriem CARRIER, Department Clinical Research of developpement |
ClinicalTrials.gov Identifier: | NCT00305552 |
Other Study ID Numbers: |
P031008 |
First Posted: | March 22, 2006 Key Record Dates |
Last Update Posted: | May 2, 2011 |
Last Verified: | January 2007 |
Randomized controlled trial Thalidomide vs placebo skin sarcoidosis Thalidomide |
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