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Accession number;99A0451284
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| Title;Skin Irritation of CLDM-T in Normal Volunteers Studied by Patch Test and Photopatch Test. |
| Author;
HARADA SHOTARO
(Nippon Telegr. and Teleph. Corp. Kanto Teishin Hosp.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.4;PAGE.559-565(1999)
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| Figure&Table&Reference;FIG.2, TBL.5, REF.5 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Skin irritation and phototoxicity of CLDM-T was investigated by means of patch test and photopatch test which were conducted in 12 healthy adult male volunteers in compliance with GCP and the study protocol. There was no withdrawal or dropout in the course of study; and consequently all subjects were evaluable for statistical analysis. Results of skin irritation index were 12.5 each in CLDM-T vehicle group, CLDM-T 1% and 2% group. Photopatch test for grade of skin reaction didn't result in the grade equal to(++) or higher grade suggesting allergic reaction; and CLDM-T 1%, 2% groups and vehicle group had the similar results of skin reaction to those of white vaseline group(control group). There was no problem in subjective symptoms, medical checkup findings and clinical laboratory tests. According to the above results, it was considered that CLDM-T 1%, 2% and the vehicle produce only minimal skin irritation and phototoxicity, suggesting that those drugs are highly safe. (author abst.) |
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