Efficacy of Itraconazole Melt-Extrusion Tablet One-week Therapy in Treatment of Hyperkeratotic Type of Tinea Pedis and/or Tinea Manus.
- Author:
Kee Chan MOON
1
;
Jai Kyoung KOH
;
Baik Kee CHO
;
Hyung Ok KIM
;
Gun Su PARK
;
Dae Gyu BYUN
;
Jin Woo KIM
;
In Kang JANG
;
Jong Yuk YI
;
Jae Bok JUN
;
Tae Jin YOON
;
Nack In KIM
;
Kyu Suk LEE
;
Chill Hwan OH
;
Soo Nam KIM
;
Sook Ja SON
;
Yong Woo CHIN
;
Dong Seok KIM
;
Gwang Yeol JOE
;
Won Woo LEE
;
Kyung Sool KWON
;
Dae Hun SUH
;
Sang Eun MOON
;
See Yong PARK
;
Kea Jeung KIM
;
Jong Suk LEE
;
Eun So LEE
;
Hyun Joo CHOI
;
Eung Ho CHOI
;
Ki Hong KIM
;
Seung Hoon CHA
;
Young Gull KIM
;
Jung Hee HAHM
;
Hae Young CHOI
;
Sung Uk PARK
;
Bang Soon KIM
;
Sang Wahn KOO
;
Byung Soo KIM
;
Young Ho WON
;
Han Uk KIM
;
Eun Sup SONG
;
Byoung Soo CHUNG
;
Byung In RO
;
Chang Kwun HONG
;
Jagn Kue PARK
;
Tae Young YOUN
;
Hee Sung KIM
;
Cheol Heon LEE
;
Kwang Joong KIM
;
Dae Won KOO
;
Jong Min KIM
;
Chang Woo LEE
;
Hee Joon YU
Author Information
- Publication Type:Original Article
- Keywords: Tinea pedis; Tinea manus; Itraconazole melt-extrusion tablet; Pulse therapy
- MeSH: Absorption; Biological Availability; Fasting; Gastric Acid; Hospitals, General; Humans; Itraconazole*; Korea; Outpatients; Tablets; Tinea Pedis*; Tinea*; Treatment Failure
- From:Korean Journal of Dermatology 1999;37(8):1047-1056
- CountryRepublic of Korea
- Language:Korean
- Abstract: 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.
