SAN FRANCISCO, CA -- March 24, 2003 -- Bexarotene, a retinoid gel indicated for the treatment of cutaneous T-cell lymphoma may also be effective for the treatment of hand dermatitis, either with or without concomitant use of topical corticosteroids.

Victor Stevens, PhD, director of medical research for the manufacturer of the drug, Ligand Pharmeceuticals Inc., in San Diego, California, United States, presented the results in a poster here on March 23^rd at the 61^st Annual Meeting of the American Academy of Dermatology.

The phase I-II open trial, led by J. Hanifin from Oregon Health Sciences University in Portland, Oregon, United States, enrolled 55 patients with severe hand dermatitis. Patients were randomised in a 2:1:1 fashion to treatment as follows: 1) bexarotene gel monotherapy; 2) bexarotene gel plus mometasone furoate (a moderate potency corticosteroid); or 3) bexarotene gel plus hydrocortisone (a low potency corticosteroid).

All treatments were applied topically for 22 weeks with a 4 week no-treatment follow-up. Dosing frequency of bexarotene was escalated from every 2 weeks to every other day, to every day, to twice daily, to three times daily.

Participants were at least 18 years of age and had experienced severe hand dermatitis for at least 6 months. Patients with allergic contact dermatitis, psoriasis, urticaria or fungal or bacterial infections were excluded from the study. Prior to initiation of therapy, all participants underwent a washout period of all previous therapies.

Based on physicians' assessment of patients' hands, 39% of patients using bexarotene gel alone experienced at least a 90% improvement in signs and symptoms of dermatitis, and 79% experienced at least a 50% improvement. These results were confirmed by secondary end points that included a sum of signs of dermatitis and the Hand Eczema Area Severity Index.

Overall, 87% of patients were escalated to at least twice daily treatment at some point in the trial, and 73% were escalated to three times daily treatment. Forty-seven percent of patients completed the trial at the three times daily dosing schedule. Despite this high frequency of use, side effects were relatively mild. Twenty-nine percent of patients experienced some irritation or rash, 15% of patients had stinging or burning and 16% experienced a dermatitis flare. Only dermatitis flare was reduced with concomitant use of the moderate potency steroid cream.

"Bexarotene represents a new class of therapy for hand dermatitis, and we're going to try this in a double-blind, placebo trial next, to see if we can develop this," Dr. Stevens said. "Many of the [participants] said that this was the most effective thing that they have tried for hand dermatitis, and these are severe, chronic patients, so all of them have tried a lot of other therapies."


[Study title: Topical Bexarotene Gel, an RXR-Selective Ligant, Improves Chronic Severe Hand Eczema. Abstract p23]

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