Evaluation of Efficacy and Safety of Topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis: An Interventional Clinical Pilot Study

Center For Research and Training in Skin Disease and Leprosy0 个研究点目标入组 15 人开始时间: 待定最近更新: 2023年2月7日

试验速览

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•Male or female subjects of any race, 18 to 60 years of age (inclusive).
•Verbal and written informed consent/assent obtained from the subject.
•Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.
•Target nails for all subjects, must have had evidence of nail growth, per subject's report that monthly clipping is needed.
•Subjects are willing to comply with study instructions and return to the vising clinic for all required appointments each 12 weeks for at least 3 visits.
•confirmed diagnosis of onychomycosis via KOH direct smear and positive culture

•Male or female who have received oral/ IV antifungal therapy within the past 12 weeks prior to screening.
•the male or female individual were used topical antifungal during the previous 4 weeks before screening
•Patients who had a history of immunosuppression /or clinical evidence indicating possible immunosuppression.
•Uncontrolled diabetics.
•Patients that have performed a surgical intervention for nail dystrophy in the past.
•Any illness or condition that could have caused nail anomalies or adversely affected the assessment. Or, presence of any nail infection other than onychomycosis or in addition to onychomycosis.
•Patients who had received immunosuppressive therapy in the past 3 months prior to screening visit or who had the need for it.
•Females who are pregnant, nursing a child, or planning a pregnancy during the study duration.

发起方

Center For Research and Training in Skin Disease and Leprosy