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A Clinical Study on the Therapeutic Efficacy of Amorolfine Cream 0.25% in Patients with Dermatomycosis
Chong Hyeok Kim, Sung Yul Lee, Soo Nam Kim
Department of Dermatology, Korea University, College of Medicine, Seoul, Korea
Vol.25 Num.4 (p375~381)
Amorolfine is a new topical antifungal drug of the phenylpropyl morpholine class which is highly active both in vitro and vivo against yeasts, dermatophytes and moulds responsible for superficial fungal infections.
In order to investigate the efficacy and safety of amorolfine cream, a clinical study was performed in the patients with dermatomycosis of the skin. A total of 33 patients with clinical symptoms and signs of mycotic infection of the skin, who had a positive mycologic culture, were included. Amorolfine cream 0.25% were applied once daily for a period of 3 weeks. Patients were excluded if they presented concurrently onychomycosis, tinea capitis, or candidiasis. The efficacy was evaluated primarily on the basis of the result of the clinical assessment and the mycological culture performed at the final evaluation 1 week ofter completion of treatment. Then, we made overall assessment of the treatment according to the following criteria, including cure, improvement, failure and not available. The results were as follows:
1) Epidemiological data: Out of the 33 patients initially included, 32 were eventully evaluable for efficacy. The main location of lestions was feet, and the majority of pathogens were T. rubrum(70%) and T. mentagrophyte (21%).
2) Clinical signs and symptoms: The most common signs and symptoms were itching, scaling and redness prior to treatment. Except scaling, virtually all symptoms subsided with treatment.
3) Mycological result: Eradication rates of dermatophytes were 81.3% at the final evaluation.
4) Overall response: The proportion of patients rated as cured or improved was 73.8%. Local adverse effects observed were transient burning and itching sensation. In one case, allergic contact dermatitis, which was confirmed by patch test, was developed.
In conclusion, amorolfine cream, administered once daily at concentration as low as 0.25% for 3 weeks, proved to be effective in dermatomycoses due to dermatophytes.
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