TY - JOUR
T1 - Efficacy of itraconazole melt-extrusion tablet one-week therapy in the treatment of hyperkeratotic type of tinea pedis and/or tinea manus
AU - Kee Chan Moon, Chan Moon
AU - Jai Kyoung Koh, Kyoung Koh
AU - Baik Kee Cho, Kee Cho
AU - Hyung Ok Kim, Ok Kim
AU - Gun Su Park, Su Park
AU - Dae Gyoo Byun, Gyoo Byun
AU - Jin Wou Kim, Wou Kim
AU - In Gang Jang, Gang Jang
AU - Jong Yuk Yi, Yuk Yi
AU - Jae Bok Jun, Bok Jun
AU - Tae Jin Yoon, Jin Yoon
AU - Nack In Kim, In Kim
AU - Kyu Suk Lee, Suk Lee
AU - Chil Hwan Oh, Hwan Oh
AU - Soo Nam Kim, Nam Kim
AU - Sook Ja Son, Ja Son
AU - Yong Woo Cinn, Woo Cinn
AU - Dong Seok Kim, Seok Kim
AU - Kwang Yeol Cho, Yeol Cho
AU - Won Woo Lee, Woo Lee
AU - Kyung Sool Kwon, Sool Kwon
AU - Dae Hun Suh, Hun Suh
AU - Sang Eun Moon, Eun Moon
AU - See Ryong Park, Ryong Park
AU - Kea Jeung Kim, Jeung Kim
AU - Jong Suk Lee, Suk Lee
AU - Eun So Lee, So Lee
AU - Hyun Joo Choi, Joo Choi
AU - Eung Ho Choi, Ho Choi
AU - Ki Hong Kim, Hong Kim
AU - Seung Hoon Cha, Hoon Cha
AU - Young Gull Kim, Gull Kim
AU - Jeong Hee Hahm, Hee Hahm
AU - Hae Young Choi, Young Choi
AU - Sung Wook Park, Wook Park
AU - Bang Soon Kim, Soon Kim
AU - Sang Wahn Koo, Wahn Koo
AU - Byung Su Kim, Su Kim
AU - Young Ho Won, Ho Won
AU - Han Uk Kim, Uk Kim
AU - Eun Sup Song, Sup Song
AU - Byoung Soo Chung, Soo Chung
AU - Byung In Ro, In Ro
AU - Chang Kwun Hong, Kwun Hong
AU - Jang Kyu Park, Kyu Park
AU - Tae Young Yoon, Young Yoon
AU - Hee Sung Kim, Sung Kim
AU - Cheol Heon Lee, Heon Lee
AU - Kwang Joong Kim, Joong Kim
AU - Dae Won Koo, Won Koo
AU - Jong Min Kim, Min Kim
AU - Chang Woo Lee, Woo Lee
AU - Hee Joon Yu, Joon Yu
PY - 1999
Y1 - 1999
N2 - 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.
AB - 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.
KW - Itraconazole melt-extrusion tablet
KW - Pulse therapy
KW - Tinea manus
KW - Tinea pedis
UR - http://www.scopus.com/inward/record.url?scp=0032757107&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:0032757107
SN - 0494-4739
VL - 37
SP - 1047
EP - 1056
JO - Korean Journal of Dermatology
JF - Korean Journal of Dermatology
IS - 8
ER -