SARCOTHAL. Thalidomide in Skin Sarcoidosis

Phase 3 Completed 40 enrolled Assistance Publique - Hôpitaux de Paris

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-02
Primary completion: 2007-11
Completion: 2007-11

Outcome

Missed primary endpoint

paper difference in proportion of -1% [95% CI, -26% to +24%] for thalidomide vs placebo, P = 1.0 PMID 24945194 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thalidomide	Other / unclassified	100 mg	Oral