Itraconazole in the treatment of superficial mycoses--a double-blind study vs. placebo.

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 in the treatment of chronic urticaria. A double-blind placebo-controlled trial.

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.

Levamisole treatment in ulcus cruris. A double-blind placebo-controlled study.

59 outpatients (27-82 years) with a chronic leg ulcer participated in a 20-week double-blind placebo-controlled trial of levamisole (levamisole 30; placebo 29). They were instructed to take a body weight adjusted number of tablets (2-5) for two consecutive days every week. Previously used topical treatment was kept unchanged. Control examinations were done every two weeks. Double-blind treatment was stopped because of evident failure after a median duration of 8 weeks in 2 levamisole and 8 placebo patients. The percentage of cured patients became significantly superior in the levamisole group from week 8 onwards, so that, by the end of the study, all levamisole patients were cured against only 76% of the controls. Three levamisole patients reported moderate gastric complaints.

A double-blind study comparing Daktacort, miconazole and hydrocortisone in inflammatory skin infections.

In a 4-week double-blind trial, Daktacort cream was compared with each of its constituents (i.e. miconazole 2% and hydrocortisone 1%) in a total of 63 patients (aged 12-60 years) with inflamed skin infections of bacterial or mycotic origin. Daktacort treatment induced a significant improvement of all symptoms within 1 week and was superior to both miconazole and hydrocortisone in suppressing the inflammation. This tendency persisted throughout the trial but at the end miconazole treatment proved also superior to hydrocortisone.