Clinical trial NCT04042857: Safety and Efficacy of Next Science Gel on Toenail Fungus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Onychomycosis of Toenail
Keywords: DSO
toenail
onychomycosis
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
Collaborators: name: Doctors Research Network
name: Tissue Analytics
name: NTS Ventures
First posted: 2019-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 18 years old and above
2. Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
3. Positive culture for dermatophytes and positive potassium hydroxide examination
4. Provide signed and dated informed consent
5. Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

1. Known allergic reaction to the study products
2. Unable to provide signed and dated informed consent form
3. Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
4. Thickness of mycotic nail is greater than 3mm
5. Less than 2mm of clear nail at the proximal aspect
6. History of rheumatoid arthritis
7. Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
8. Unwilling or unable to limit use of nail polish for duration of study
9. Known history of PVD, immune system concerns, or ongoing chemotherapy
10. Severe moccasin tinea pedis
11. Prior systemic antifungal drugs 6 months before study start date
12. Prior topical therapy for toenail fungus 2 months before study start date
13. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Primary outcomes:
measure: Mycological Cure at 48 Weeks
timeFrame: Baseline to 48 Weeks
measure: Clinical Efficacy at 48 Weeks
timeFrame: Baseline to 48 Weeks
Secondary outcomes:
measure: Complete Cure at Week 48
timeFrame: Baseline to 48 Weeks
measure: Complete Cure at Week 52
timeFrame: Baseline to 52 Weeks
measure: Almost Complete Cure at Week 48
timeFrame: Baseline to 48 Weeks
measure: Almost Complete Cure at Week 52
timeFrame: Baseline to Week 52
measure: Time to Complete Cure
timeFrame: Baseline to 52 Weeks
measure: Time to Almost Complete Cure
timeFrame: Baseline to 52 Weeks
measure: Percent Change in Area of Nail Involvement
timeFrame: Baseline to 52 Weeks
measure: Growth of Clear Nail
timeFrame: Baseline to 52 Weeks
measure: Mycological Cure Rate
timeFrame: Baseline to 52 Weeks
measure: Dermatopyhyte Identification and Characterization
timeFrame: Baseline to 52 Weeks
measure: Overall Fungal Species
timeFrame: Baseline to 52 Weeks
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
Study officials:
affiliation: Doctors Research Network
name: Maria S Surprenant, DPM
role: PRINCIPAL_INVESTIGATOR
References: