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Crossover study of thalidomide vs placebo in Jessner's lymphocytic infiltration of the skin.

BACKGROUND AND DESIGN
An effective therapy is still unavailable for Jessner-Kanof lymphocytic infiltration of the skin. Thalidomide's efficacy was suggested in an open study. Twenty-eight patients were randomly assigned to receive thalidomide (100 mg/d) or placebo over a period of 2 months and were then switched to the other treatment.


RESULTS
After the first period, 11 of 13 patients treated with thalidomide were in complete remission (CR), and there were two failures. There was no CR in the patients who received placebo (chi y2 = 17.5; P < .0001). After the second period, nine of 14 patients who had received thalidomide were in CR. Eleven of the 13 patients who had received thalidomide during the first period were given placebo (two were unavailable for follow-up). Ten of them were in CR: four were still free of lesions at the end of the second period, and six experienced a relapse of their lesions after a mean duration of 26 +/- 10 (SD) days. A total of 25 patients participated in the two study periods; CR was observed in 19 (76%) after thalidomide therapy and in four (16%) after treatment with placebo (chi y2 = 11.1; P < .001). Of 27 patients who received thalidomide, 16 (59%) were in CR after 1 month and 20 (74%) were in CR after 2 months. Two patients treated with thalidomide experienced neurologic changes that were not consistent with typical thalidomide-induced neuropathy.


CONCLUSIONS
A therapeutic regimen of thalidomide administered at a dosage of 100 mg/d for 2 months is able to suppress the clinical symptoms of Jessner-Kanof lymphocytic infiltration of the skin. The long-term risk-benefit has still to be evaluated.