Onychomycosis of Toenail Clinical Trial
Official title:
Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.
Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48
weeks once approved for participation. Analysis will be attained via potassium hydroxide
examination (KOH test), nail culture, PCR analysis, and photographic imaging. Subjects may
have both hallux nails sampled at screening for culture and KOH testing if both hallux nails
appear to meet the criteria for study inclusion. Only subjects with both a positive culture
and KOH examination will start study treatment. Subjects may have repeat KOH and culture
testing both performed if the first screening test results in at least one of the tests being
negative. At investigator's discretion, other affected toenails besides the study target
hallux nail may be treated but will not be included for analysis. Patients will come for
in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12,
week 24, week 36, week 48, and week 52.
If subjects achieve complete cure (as defined by mycological cure and 0% nail involvement)
prior to Week 48, patients will be encouraged to continue in the trial with active treatment
for the full protocol.
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