Efficacy of itraconazole melt-extrusion tablet one-week therapy in the treatment of hyperkeratotic type of tinea pedis and/or tinea manus

Chan Moon Kee Chan Moon, Kyoung Koh Jai Kyoung Koh, Kee Cho Baik Kee Cho, Ok Kim Hyung Ok Kim, Su Park Gun Su Park, Gyoo Byun Dae Gyoo Byun, Wou Kim Jin Wou Kim, Gang Jang In Gang Jang, Yuk Yi Jong Yuk Yi, Bok Jun Jae Bok Jun, Jin Yoon Tae Jin Yoon, In Kim Nack In Kim, Suk Lee Kyu Suk Lee, Chil Hwan Oh, Nam Kim Soo Nam Kim, Ja Son Sook Ja Son, Woo Cinn Yong Woo Cinn, Seok Kim Dong Seok Kim, Yeol Cho Kwang Yeol Cho, Woo Lee Won Woo LeeSool Kwon Kyung Sool Kwon, Hun Suh Dae Hun Suh, Eun Moon Sang Eun Moon, Ryong Park See Ryong Park, Jeung Kim Kea Jeung Kim, Suk Lee Jong Suk Lee, So Lee Eun So Lee, Joo Choi Hyun Joo Choi, Ho Choi Eung Ho Choi, Hong Kim Ki Hong Kim, Hoon Cha Seung Hoon Cha, Gull Kim Young Gull Kim, Hee Hahm Jeong Hee Hahm, Young Choi Hae Young Choi, Wook Park Sung Wook Park, Soon Kim Bang Soon Kim, Wahn Koo Sang Wahn Koo, Su Kim Byung Su Kim, Ho Won Young Ho Won, Uk Kim Han Uk Kim, Sup Song Eun Sup Song, Soo Chung Byoung Soo Chung, In Ro Byung In Ro, Kwun Hong Chang Kwun Hong, Kyu Park Jang Kyu Park, Young Yoon Tae Young Yoon, Sung Kim Hee Sung Kim, Heon Lee Cheol Heon Lee, Joong Kim Kwang Joong Kim, Won Koo Dae Won Koo, Min Kim Jong Min Kim, Woo Lee Chang Woo Lee, Joon Yu Hee Joon Yu

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Abstract

Backgrounds: 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 manus 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, defined 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.

Original languageEnglish
Pages (from-to)1047-1056
Number of pages10
JournalKorean Journal of Dermatology
Volume37
Issue number8
Publication statusPublished - 1999 Nov 22
Externally publishedYes

Keywords

  • Itraconazole melt-extrusion tablet
  • Pulse therapy
  • Tinea manus
  • Tinea pedis

ASJC Scopus subject areas

  • Dermatology

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    Kee Chan Moon, C. M., Jai Kyoung Koh, K. K., Baik Kee Cho, K. C., Hyung Ok Kim, O. K., Gun Su Park, S. P., Dae Gyoo Byun, G. B., Jin Wou Kim, W. K., In Gang Jang, G. J., Jong Yuk Yi, Y. Y., Jae Bok Jun, B. J., Tae Jin Yoon, J. Y., Nack In Kim, I. K., Kyu Suk Lee, S. L., Oh, C. H., Soo Nam Kim, N. K., Sook Ja Son, J. S., Yong Woo Cinn, W. C., Dong Seok Kim, S. K., Kwang Yeol Cho, Y. C., ... Hee Joon Yu, J. Y. (1999). Efficacy of itraconazole melt-extrusion tablet one-week therapy in the treatment of hyperkeratotic type of tinea pedis and/or tinea manus. Korean Journal of Dermatology, 37(8), 1047-1056.