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IRCT20150101020514N18 IRCT 2023-01-05 Center For Research and Training in Skin Disease and Leprosy Efficacy of topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis amb Evaluation of Efficacy and Safety of Topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis: An Interventional Clinical Pilot Study 2021-06-26 anticipated 15 Complete https://irct.ir/trial/38071 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Fungal nail Infection. 0.4% nano-liposomal amphotericin B gel is prescribed for the patients after they are educated on how to properly use the medication. Patients are asked to apply the gel topically twice daily on the entire surface of the affected nails and on a 6mm margin around the cuticle. The treatment must be done minimum 12 weeks for patient with finger nail onychomycosis and 24 weeks for those with toe nail onychomycosis.. Yes - There is a plan to make this available What will be shared: Only in published article When: After publication of article To whom: Clinicians, pharmacologist, medical mycologist Conditions: ----- Where to obtain: Center for Research and Training in Skin Disease and Leprosy How to obtain: After publication of article Comments:

public Dr. Alireza Firooz

Taleghani ave

Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 alifiruz@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz

Taleghani ave

Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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. L62.8 Nail disorders in other diseases classified elsewhere Treatment - Other 0.4% nano-liposomal amphotericin B gel is prescribed for the patients after they are educated on how to properly use the medication. Patients are asked to apply the gel topically twice daily on the entire surface of the affected nails and on a 6mm margin around the cuticle. The treatment must be done minimum 12 weeks for patient with finger nail onychomycosis and 24 weeks for those with toe nail onychomycosis. State of clinical response, including: 1-partial clinical improvement which means decrease in the nail surface involvement to 10 -50% nail bed surface , or complete cure which means decrease in the nail surface involvement to <10% nail bed surface. Timepoint: Base ( first visit) / week 12/ week 24 / week 36. Method of measurement: Physical examination, direct examination and culture for fungal elements. Mycological cure. Timepoint: Base ( first visit) / week 12/ week 24 / week 36. Method of measurement: Physical examination, direct examination and culture for fungal elements. Center For Research and Training in Skin Disease and Leprosy Approved 2019-06-18 National Research Ethics Committee of Tehran University Tehran university of medical science Tehran Tehran Iran (Islamic Republic of)