Phase II clinical trial of bexarotene gel 1% in psoriasis.

We report the results of a nonrandomized, open-label pilot trial investigating the safety, tolerability, and efficacy of bexarotene gel 1% in treating chronic mild to moderate plaque psoriasis. Twenty-four adults with mild to moderate stable plaque psoriasis involving 15% or less of their body surface were enrolled. Patients applied bexarotene gel 1%, using an application frequency escalation regimen, starting at once every other day and increasing to 4 times daily as tolerated and beneficial for up to 24 weeks. The primary efficacy instrument was a Physician's Global Assessment (PGA) score evaluating the overall response to treatment. This utilized individual signs of psoriasis and the percent of body surface area involvement. Safety assessments included physical examinations, recording of adverse events, and laboratory safety evaluations. Fifteen out of 24 enrolled patients (63%) achieved at least 50% improvement by PGA score at 2 or more consecutive visits, and 6 (24%) achieved clearing of 90% or more. Six patients maintained a response throughout 8 weeks of follow-up. An increased response appeared to correlate with a higher frequency of gel application. Adverse events occurred primarily at application sites and were mild or moderate in severity. Bexarotene gel 1% was active in treating mild to moderate plaque psoriasis with achievement of durable responses in some patients and was well-tolerated. A randomized, placebo-controlled study would be useful in confirming these results.