Efficacy of topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis

Phase 2

Conditions: Fungal nail Infection.
Nail disorders in other diseases classified elsewhere
L62.8

Registration Number: IRCT20150101020514N18

Lead Sponsor: Center For Research and Training in Skin Disease and Leprosy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures