Tinea manus treated with 1‐week itraconazole vs. terbinafine

A double‐blind, prospective, comparative, randomized study was conducted to determine the efficacy and safety of itraconazole (pulse) given for 1 week against a 2‐week course of terbinafine (continuous) for the treatment of tinea manus. The inclusion criteria were that the clinical diagnosis of tinea manus had to be confirmed by positive mycologic examination (KOH). Individuals had to be 18 years or older and in good general health. Patients with a sensitivity to imidazole or the allylamine derivative were excluded, as were subjects participating in any other investigational drug study within 4 weeks prior to the start of the trial. Other exclusion criteria included women who were pregnant, lactating, or in whom there was a lack of adequate contraception. Patients with a history of chronic liver disease were also excluded, as were individuals with a tinea infection at another anatomic site. Patients receiving any agents known to have an interaction with either itraconazole or terbinafine, including rifampin, phenytoin, digoxin, warfarin, astemizole, terfenadine, cisapride, simvastatin, and lovastatin, were excluded from the study. The patients must not have received systemic antifungal or corticosteroid therapy for at least 30 days, or applied topical antifungals or corticosteroids for at least 14 days, prior to the onset of the study. Patients were withdrawn from the study if a serious adverse event occurred which, in the opinion of the investigator or participant, merited discontinuation from the trial, if the randomization code was broken, or if the subject withdrew consent. Patients were evaluated at baseline, week 1, week 2 (end of double‐blind treatment phase), and week 6 from the start of treatment. The primary efficacy measure was the mycologic cure rate (negative light microscopic examination and culture, or one test negative and the other not positive). The secondary assessment included the clinical global evaluation: healed (absence of signs and symptoms), markedly improved (≥ 50% clinical improvement), considerable residual lesions (< 50% clinical improvement), no change, or worsening. The three symptoms that were evaluated were desquamation, erythema, and pruritus. The severity of the symptoms was graded as: absent, 0; mild, 1; moderate, 2; severe, 3. Clinical success was defined as occurring when patients were healed or markedly improved. Any adverse event that occurred was recorded. The study was approved by an ethical committee and informed consent was obtained from each patient.