Itraconazole Pulse Therapy for Onychomycosis of Toenail: An Open Multicenter Trial

Jun, Jae Bok; Kwon, Kyung Sool; Park, Jang Kyu; Kim, Ki Hong; Kim, Sang Tae; Lee, Sung Hoon

Abstract

BACKGROUND: Toenail onychomycosis still remains difficult to treat. Pulse therapy of itraconazole is frequently prescribed to lighten the patient's burden of economical problems, frequent side effects, resulting in good compliance.
OBJECTIVE
The purpose of this study is to evaluate the clinical efficacy and adverse reactions of pulse therapy of itraconazole.
METHODS
From March to September 1996, a total of 108 patients with onychomycosis of toenail diagnosed at Department of Dermatology of 5 university hospitals, were enrolled in a subject group for the study. Itraconazole was administered, 200 mg twice daily, in every first week of 3 consecutive months. Clinical symptoms and sings with or without mycologic findings were assessed at baseline, at the end of 4, 8, 12, 24, 36 and 48 weeks after the start of therapy.
RESULTS
Fifty six patients (male 22, female 34; mean age 44.0+/-13.3) completed the follow-ups. As causative agents, Trichophyton(T.) rubrum was isolated in 51 of them, T. mentagrophytes 2, and yeast 3. Decrease in initial percentages of patients showing pathologic changes in target nail at the last follow-up 12 months after starting therapy : for onycholysis, from 51.8% to 21.4%; for subungual hyperkeratosis, from 96.4% to 39.3%; for nail discoloration, from 100.0% to 50.0%. Mycological cure rate was 82.1% at the last follow-up. Overall clinical responses evaluated at the last follow-up were cured in 28 patients (50.0%), 'markedly improved' in 15 (26.8%), 'moderately improved' in 9 (16.1%), and 'deteriorated' in 4 (7.1%), making a clinical response rate of 92.9%. During therapy, transient epigastric pain and indigestion developed in 2 patients (3.6%), respectively.
CONCLUSION
With these results, itraconazole pulse therapy is considered an effective and safe treatment modality for onychomycosis of toenail.