The Efficacy and Safety of Short-term Therapy with Itraconazole Melt-Extrusion Tablet in The Hyperkeratotic Type of Tinea Pedis and/or Tinea Manus / 대한의진균학회지

BACKGROUND: The many antifungal agents have been used in fungal infections. In usual trial agents, itraconazole still remains difficult to absorption in gastrointestinal tract. OBJECTIVE: The purpose of this study is to evaluate the clinical efficacy and adverse reactions of short-term itraconazole melt-extrusion tablet increased in hyperkeratotic type of tinea pedis and/or tinea mauns. METHODS: From November 1998 to February 1999, a total of 60 patients with palmoplantar type of tinea pedis and/or tinea manus at Department of Dermatology of 5 general hospital, were enrolled in a subject group for the study. Itraconazole melt-extrusion tablet was administered, 200mg twice daily, in one week. Clinical symptoms and signs with mycological findings were assessed. RESULTS: Fifty-six patients (male 33, female 23; mean age 36.1+/-10.7; mean duration 6.5+/-4.8) completed the follow-ups. Direct KOH smear examination was positive in all them. Decrease in initial percentages of patients showing symptoms at the last follow-up 2 months after starting therapy: for scale, from 100% to 85.4%; for ertyema, from 91.1% to 10.7%; for hyperkeratosis from 100% to 32.3%; for pruritus, from 82.1% to 10.7%. Mycologic cure rate was 92.9% at the last follow-up. Overall clinical responses evaluated at the last follow-up were 'cured' in 6 pathients(10.7%), 'markedly improved' in 38 patiendts(67.9%), making a clinical response rate of 78.6%. During therapy, transient epigastria pain and indigeastion developed in 5 patients(8.9%). CONCLUSION: With these results, itraconazole melt-extrusion table is considered an effective and safe treatment modality for hyperkeratotic type of tinea pedis and/or tinea manus.

Efficacy of Itraconazole Melt-Extrusion Tablet One-week Therapy in Treatment of Hyperkeratotic Type of Tinea Pedis and/or Tinea Manus / 대한피부과학회지

BACKGROUND: Since the bioavailability of itraconazole capsule is influenced by patients gastric acidity, it results in treatment failure due to its low dissolution and subsequent low absorption when administered in fasting. Itraconazole Melt-Extrusion tablet has been lately developed in order to improve its dissolution profile. It is the first clinical study to evaluate the efficacy and safety of itraconazole Melt-Extrusion tablet in Korea. OBJECTIVE: This study was conducted to evaluate the efficacy and safety of itraconazole melt-extrusion tablet 400mg daily for 1 week(pulse therapy) for hyperkeratotic type of tinea pedis and manus. METHODS: A clinical and mycological investigation was made of 812 outpatients with hyperkeratotic type of tinea pedis and/or tinea manus who had visited at 52 general hospitals under the lead of the Korean Dermatological Association from June to December, 1998. Patients confirmed by clinically and microscopically as hyperkeratotic type of tinea pedis and/or tinea manus were administered 2 tablets twice a day for one week and followed up for 8 weeks from the start of the medication. RESULTS: The results were summarized as follows; 1. Clinical symptoms of hyperkeratotic type of tinea pedis and/or tinea mauns were significantly improved at the end of study, week 8(p<0.001). 2. Clinical response rate, defined as more than 50% decrease of the sum of the clinical symptom scores, was 79.3%(512/646). 3. Mycological cure rate, dafined as both culture and KOH negative at week 8, was 78.2%(244 /312). 4. 40(5.5%) patients, of the 727 patients evaluable for drug safety evaluation, were reported to have adverse event. CONCLUSION: Itraconazole Melt-Extrusion tablet 400mg/day for 1 week (pulse therapy) is effective and safe in the treatment of hyperkeratotic type of tinea pedis and/or tinea manus.