Efficacy

We found two randomised double-blind, vehicle-controlled trials of the use of alitretinoin (9-c/s-retinoic acid) gel in the topical treatment of AIDS-related KS.78,79 The larger one, a multicentre randomised double-blind trial involving 268 patients with AIDS-related cutaneous KS, compared 0.1% alitretinoin gel with vehicle gel, applied twice daily for 12 weeks.79 Concurrent antiretroviral therapy was allowed. Six index lesions were used to assess response to therapy using ACTG criteria applied to topical therapy. The overall response rate (complete and partial responses) was 35% (45/134) in the alitretinoin group compared with 18% (24/134) for the vehicle group. Following the blinded phase of the study, 184 of the patients were then treated with alitretinoin gel on an open-label basis and the overall response rate was 49% (90/184).79

In another randomised double-blind vehicle-controlled study, patients were randomised between 0-1% alitretinoin gel and vehicle gel, applied twice daily for 12 weeks.78. The overall response rate, assessed by ACTG criteria applied to topical therapy, for 62 patients treated with alitretinoin was 37% compared with 7% for 72 patients who received vehicle gel (P= 0-00003).

Alitretinoin was superior to vehicle gel in both the above studies when multiple variables, including number of lesions, CD4 count, performance status and number of concurrent antiretroviral therapies, were adjusted for.

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