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The purpose of this double-blind study was to compare the therapeutic effects of a low initial dosage of acitretin, increased at 2-week intervals (group 1:10, 30, 50 mg/day) with a high initial dosage decreased at similar intervals (group 3: 50, 30, 10 mg/day) and with a constant dosage (group 2: 30 mg/day) in 66 patients (47 men and 19 women) with severe psoriasis. At the end of the double-blind phase the mean percent improvement calculated by the Psoriasis Area and Severity Index score, was as follows: 62.7% in group 1, 55.9% in group 2 and 67.1% in group 3.The double-blind phase of 6 weeks was followed by an open phase of 6 weeks, during which the patients were treated either with 10, 30 or 50 mg/day, according to the therapeutic response. At the end of treatment (12 weeks), a mean improvement of more than 80% was obtained in all three groups. Hypervitaminosis A signs and symptoms were observed in all patients. The frequency and severity of these adverse reactions were shown to be dose-dependent. This study shows that a low dose progressively increased is advisable because of similar activity and better acceptability.

Extensive lesions on 36 patients with psoriasis were treated by Tigason, I mg/kg/day plus PUVA until skin clearance. A clinical score was calculated for each body area, and erythema, scaling, thickness and pruritus of the lesions were scored from 0 to 3. Skin clearing was defined as a clinical score less than 10% of the initial score. Double-blind maintenance treatment was then started. This was Tigason at half of the maximal dose tolerated during the clearing phase of the treatment v. placebo. Relapse of the disease was defined as the occurrence of a clinical score greater than 50% of the initial score. Among the 36 patients randomized, 20 received placebo and 16 received Tigason. Relapses increased quickly in the patients on placebo, but occurred in few patients treated by Tigason with 60% remaining clear after 1 year (P less than 0.05). Surprisingly, the kinetics of disappearance of the most frequent side effect, cheilitis, was the same in the Tigason group and in the placebo group. This double-blind randomized clinical trial shows that Tigason at low doses is an efficient and well-tolerated maintenance treatment of psoriasis.

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