Dermatitis - alitretinoin
The vitamin A derivative alitretinoin is already approved in some countries for the treatment of Kaposi's sarcoma, and is an endogenous retinoid that activates both retinoic acid receptors and retinoid X receptors.1
The vitamin A derivative alitretinoin is already approved in some countries for the treatment of Kaposi's sarcoma, and is an endogenous retinoid that activates both retinoic acid receptors and retinoid X receptors.1
It has subsequently been developed by Basilea as a treatment for chronic hand dermatitis. This comes in many forms, including contact dermatitis, hyperkeratotic, frictional and atopic; all of these exist in both acute and chronic forms.
In an initial trial, a total of 38 patients with refractory chronic eczema of the hand were given oral doses of alitretinoin in an open label study.2 More than half had a very good response, and most of the rest a good response - only two subjects did not respond. The side-effects reported were only mild.
In a Phase II trial, a total of 319 patients with chronic hand dermatitis were given 10, 20 or 40mg of the drug or placebo a day for 12 weeks.3 The response rates were 39, 41 and 53% respectively, with 27% of those given placebo responding. All types of hand dermatitis responded, including a number of cases who had had no relief from any previous form of treatment. It was generally well tolerated, and adverse event rates were similar among the placebo group and those given the two lower doses. In the group given 40mg, adverse events included flushing, headache and raised serum lipid levels. About a quarter of those who had initially responded had a relapse during the subsequent three months.
A prospective, randomised, placebo-controlled, parallel group Phase III trial has also been carried out.4 A total of 1,032 patients with chronic hand dermatitis were given 10 or 30mg of the drug or placebo once a day for 12 or 24 weeks, with the duration of treatment depending on the response achieved. Almost half of those given the higher dose were clear or almost clear of disease after the treatment period; response rates for the lower dose and placebo were 28% and 17% respectively. Higher levels of adverse events were seen in those given the higher dose, with 1% of each of the three groups reporting severe adverse events.