Safety and Efficacy of Next Science Gel on Toenail Fungus
ConditionOnychomycosis of Toenail
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNext Science TM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Next Science Treatment Gel
DeviceNext Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Next ScienceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 Weeks2
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 WeeksSecondary outcomes
1
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 Weeks2
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 Weeks3
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 Weeks4
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 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Next Science TM
Lead sponsor
Doctors Research Network
Collaborator
Tissue Analytics
Collaborator
NTS Ventures
Collaborator
Source ClinicalTrials.gov