An interventional study of Next Science Treatment Gel in Onychomycosis of Toenail, sponsored by Next Science TM. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Next Science TM · Not applicable, Interventional, and Treatment
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.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Next Science TM is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.
Device: Next Science Treatment Gel
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Mycological 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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for Oct 2020, 14 months after the start.
Of 21 interventional studies with no phase under Onychomycosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's planned 14 months is close to that.
How these figures are worked out, and which studies are left out of them.
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