Fungal nail Infection. Nail disorders in other diseases classified elsewhere
Conditions
Interventions
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 en
Sponsors
Center For Research and Training in Skin Disease and Leprosy
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Alireza Firooz
Tehran University of Medical Sciences
Outcome results
None listed