０．７５％硝酸ミコナゾール配合シャンプーのフケ症に対する臨床評価―多施設共同一般臨床試験

DOI 被引用文献2件 参考文献17件 オープンアクセス

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  • Clinical Evaluation of Shampoo Containing 0.75% Miconazole Nitrate for Dandruff.

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Efficacy of anti-dandruff shampoo containing 0.75% miconazole nitrate was evaluated in clinical trials conducted at 8 institutions.<br>Out of 60 subjects, 58 were evaluated for safety, 49 for effectiveness, excluding those deviating from the protocol, and 50 for usefulness.<br>In the assessment of effectiveness, of the 49 subjects there was significant improvement in 12 (24%), moderate improvement in 24 (49%), a mild effect in 6 (12%) and no effect in 7 (14%). The final improvement rating of effectiveness was 73%, indicating clinical usefulness of the shampoo. Decrease in dandruff and itching was observed in 82% and 74% of the subjects, respectively.<br>An adverse effect was seen in one out of 58 subjects (2%), with irritation by miconazole nitrate or one of the basic ingredients of the shampoo being suspected from the results of patch testing. Three days after using the shampoo this subject complained of mild pruritus in the post-auricular region, though there was no visible sign such as erythema. The symptom disappeared without treatment when the individual stopped using the shampoo.<br>Evaluations by the subjects at the end of the trial showed that dandruff and itching decreased in 76% and 79%, respectively, which corresponded well to evaluations by doctors. Compared with shampoo containing conventional anti-dandruff agents it was also evaluated as more effective by 13 out of 17 subjects (76%).<br>In conclusion, a shampoo containing miconazole nitrate was found to be effective and safe when used as an anti-dandruff shampoo, confirming its benefits as the first anti-dandruff shampoo with this antifungal agent in Japan.

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