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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Doctors Research Network
South Miami, Florida, United States
RECRUITINGMycological Cure at 48 Weeks
Mycological cure rate at week 48 as defined by negative potassium hydroxide examination and negative culture of the target hallux nail
Time frame: Baseline to 48 Weeks
Clinical Efficacy at 48 Weeks
Clinical efficacy rate at week 48 as defined by less than 10% clinical involvement of the target hallux nail
Time frame: Baseline to 48 Weeks
Complete Cure at Week 48
Complete cure rate at week 48 defined as 0% clinical involvement, negative potassium hydroxide examination and negative culture of the target hallux nail
Time frame: Baseline to 48 Weeks
Complete Cure at Week 52
Complete cure rate at week 52 defined as 0% clinical involvement, negative mycology, and negative potassium hydroxide examination of the target hallux nail at week 52
Time frame: Baseline to 52 Weeks
Almost Complete Cure at Week 48
Almost complete cure rate at week 48 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at week 48
Time frame: Baseline to 48 Weeks
Almost Complete Cure at Week 52
Almost complete cure rate at week 52 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at Week 52
Time frame: Baseline to Week 52
Time to Complete Cure
Measured across all observation points
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Time frame: Baseline to 52 Weeks
Time to Almost Complete Cure
Measured across all observation points
Time frame: Baseline to 52 Weeks
Percent Change in Area of Nail Involvement
Calculated as a ratio of clear to involved measured across all observation points
Time frame: Baseline to 52 Weeks
Growth of Clear Nail
Change in area of clear nail growth measured across all observation points
Time frame: Baseline to 52 Weeks
Mycological Cure Rate
Changes in mycological cure rates (Changes in the proportion of subjects who achieved mycological cure, defined as negative culture and potassium hydroxide examination) measured across all observation points
Time frame: Baseline to 52 Weeks
Dermatopyhyte Identification and Characterization
Changes in the types of dermatophytes dermatophytes across all observation points
Time frame: Baseline to 52 Weeks
Overall Fungal Species
Change types of overall fungal species across all observation points
Time frame: Baseline to 52 Weeks