Korean J Dermatol.
1999 Aug;37(8):1047-1056.
Efficacy of Itraconazole Melt-Extrusion Tablet One-week Therapy in Treatment of Hyperkeratotic Type of Tinea Pedis and/or Tinea Manus
- Affiliations
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- 1Department of Dermatol, Asan Medical Center.
- 2Department of Dermatol, Catholic University of Korea.
- 3Department of Dermatol, Kyungpook National University.
- 4Department of Dermatol, Gyeongsang National University.
- 5Department of Dermatol, Kyung Hee University.
- 6Department of Dermatol, Keimyung University.
- 7Department of Dermatol, Korea University.
- 8Department of Dermatol, National Medical Center.
- 9Department of Dermatol, Dankook University.
- 10Department of Dermatol, Catholic University of Taegu Hyosung.
- 11Department of Dermatol, Dong A University.
- 12Department of Dermatol, Marynoll University.
- 13Department of Dermatol, Pusan National University.
- 14Department of Dermatol, Seoul National University.
- 15Department of Dermatol, Seoul Red Cross Hospital.
- 16Department of Dermatol, Sung Kyun Kwan University.
- 17Department of Dermatol, Soonchunhyang University.
- 18Department of Dermatol, Ajou University.
- 19Department of Dermatol, Yonsei University.
- 20Department of Dermatol, Yonsei University Wonju College of Medicine.
- 21Department of Dermatol, Youngnam University.
- 22Department of Dermatol, Won Kwang University.
- 23Department of Dermatol, Eulji General Hospital.
- 24Department of Dermatol, Ewha Womans University.
- 25Department of Dermatol, Inje University.
- 26Department of Dermatol, Inha University.
- 27Department of Dermatol, Chonnam University.
- 28Department of Dermatol, Chonbuk National University.
- 29Department of Dermatol, Chonju Presbyterian Medical Center.
- 30Department of Dermatol, Chosun University.
- 31Department of Dermatol, Chung Ang Unversity.
- 32Department of Dermatol, Chungnam National University.
- 33Department of Dermatol, Chungbuk National University4.
- 34Department of Dermatol, Pochun CHA Medical School.
- 35Department of Dermatol, Hallym University.
- 36Department of Dermatol, Hanyang University.
Abstract
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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.
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