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Recruiting NCT04042857

Safety and Efficacy of Next Science Gel on Toenail Fungus

No phase Interventional Onychomycosis of Toenail

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Next Science Treatment Gel.
Who it may be relevant to
Registry conditions: Onychomycosis of Toenail. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Next Science Treatment Gel
    Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.

Primary outcome measures

  • Mycological Cure at 48 Weeks [Time frame: Baseline to 48 Weeks]
  • Clinical Efficacy at 48 Weeks [Time frame: Baseline to 48 Weeks]
Secondary outcome measures (11)
  • Complete Cure at Week 48 [Time frame: Baseline to 48 Weeks]
  • Complete Cure at Week 52 [Time frame: Baseline to 52 Weeks]
  • Almost Complete Cure at Week 48 [Time frame: Baseline to 48 Weeks]
  • Almost Complete Cure at Week 52 [Time frame: Baseline to Week 52]
  • Time to Complete Cure [Time frame: Baseline to 52 Weeks]
  • Time to Almost Complete Cure [Time frame: Baseline to 52 Weeks]
  • Percent Change in Area of Nail Involvement [Time frame: Baseline to 52 Weeks]
  • Growth of Clear Nail [Time frame: Baseline to 52 Weeks]
  • Mycological Cure Rate [Time frame: Baseline to 52 Weeks]
  • Dermatopyhyte Identification and Characterization [Time frame: Baseline to 52 Weeks]
  • Overall Fungal Species [Time frame: Baseline to 52 Weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Doctors Research Network — South Miami

Identifiers

NCT: NCT04042857 · CSP-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗