One hundred and twenty-four patients who had had recurrent aphthous stomatitis (RAS) for two to 53 years took part in three studies to assess the effectiveness of levamisole and determine an adequate regimen. In study 1 and the first half of study 2 both of which were double-blind, levamisole 150 mg/day (or placebo) was given on three consecutive days in every fortnight. In the second two months of study 2 and in the open trial (study 3) three-day courses were given only when an episode of RAS occurred. The drug was well tolerated. The signs and symptoms of RAS improved gradually and significantly in those treated with levamisole but not in those on placebo, and intergroup differences were also significantly in favour of the active drug. Improvement occurred earlier in study 3 than in the other two studies. Hence levamisole may prevent new episodes of RAS.
Ninety-four patients with dermatophytosis and 16 patients with pityriasis versicolor were assigned under double-blind conditions to oral itraconazole (100 mg once daily) or placebo. The medication consisted of two capsules, each containing 50 mg of active substance, or placebo and was given for 15 or 30 days in patients with dermatophytosis and for 15 days in patients with pityriasis versicolor. Patients with pityriasis versicolor who had not responded at the end of the double-blind period were treated on an open basis with itraconazole (100 mg once daily) for 15 days. In the treatment of dermatophyte infections for 30 days, both clinical response and mycological cure were significantly superior in the itraconazole group compared with placebo. Oral administration of itraconazole (100 mg once daily) was also highly efficacious in the treatment of pityriasis versicolor. None of the placebo patients was clinically or mycologically cured at the end of the double-blind phase compared to seven out of eight itraconazole patients. All placebo patients who entered the open phase responded to itraconazole treatment. Three itraconazole-treated patients and nine placebo-treated patients reported side-effects.
Oxatomide was evaluated in a double-blind study of 35 patients with chronic urticaria. For 5 weeks patients received at random either 30 mg oxatomide b.i.d. or a placebo. Oxatomide significantly reduced not only the duration of the attacks but also the severity of erythema, lesions and itching. This lower level of suffering was clearly reflected by a diminished need for additional antiallergic medication. The overall response to treatment was rated excellent or good in 72% of the oxatomide-treated patients against only 23% of the controls which is a significant difference. Sleepiness was reported in 1 patient of each group.
A new oral antimycotic, the imidazole drug ketoconazole, was tested in 67 cases of fungal infections of the skin or the nails. One tablet of 200 mg ketoconazole was given daily. Eighty-five per cent of the patients with dermatomycoses were clinically cured by the end of the six-week treatment. Among them were four patients with a persistent mycosis on the volar side of the hand. Most patients with onychomycoses were still being treated a t the time of this evaluation. In all of them healthy nails had been normally growing again. N o adverse effects were noted. Zusammenfassung: Ein neues orales Antimykotikum, das Imidazol-Praparat Ketoconazol, wurde bei 67 Patienten mit Pilzinfektionen von Haut und Nageln gepruft. Es wurde tsglich eine Tablette zu 200 mg Ketoconazol verabreicht. Fiinfundachtzig Prozent der Patienten rnit Dermatomykosen waren am Ende der sechswochigen Behandlung klinisch geheilt. Darunter waren vier Patienten mit einer hartnlckigen Mykose an der Handflache. Die nieisten Patienten mit Onychomykosen wurden zur Zeit dieser Auswertung noch weiterbehandelt. Alle zeigten eine gesunde Nagelbildung. Es wurden keine Nebenwirkungen beobachtet. 715-721.
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