Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
Study NCT ID:
NCT04042857
Status:
RECRUITING
Last Update Posted:
2019-08-02
First Post:
2019-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Next Science Gel on Toenail Fungus
Sponsor:
Next Science TM
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: