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CompletedNCT00305552Updated May 2, 2011

SARCOTHAL. Thalidomide in Skin Sarcoidosis

A Phase 3 interventional study of THALIDOMIDE in Sarcoidosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoidosis

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Keywords

  • Randomized controlled trial
  • Thalidomide vs placebo
  • skin sarcoidosis
  • Thalidomide
03

In context

Sarcoidosis

278 studies on the registry are indexed under Sarcoidosis; 57 are open to participants now.

This study's enrollment of 40 is below the median of 54 across 154 interventional studies indexed under Sarcoidosis.

Browse Sarcoidosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Biopsy proven skin sarcoidosis
  • Assessable target skin lesions

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    THALIDOMIDE

    Drug: THALIDOMIDE

Interventions

  • DrugTHALIDOMIDE

    THALIDOMIDE

06

What researchers measure

Primary outcomes

  1. Size of target skin lesions at 3 months.

    Size of target skin lesions at 3 months.

    Time frame: during de study

Secondary outcomes

  1. 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.

    Time frame: during the study

07

Study locations

1 site
  • HOPITAL Saint Louis, Service de Dermatologie
    Paris, 75010, France
08

References and documents

Publications

  • Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015. PubMed 24945194 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00305552
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
Mar 22, 2006
Start date
Feb 2005
Primary completion
Nov 2007
Completion
Nov 2007
Last update
May 2, 2011

Study contacts

Michel RYBOJAD, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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