Onychomycosis
Conditions
Keywords
chronic persistent infection of the nail bed or plate
Brief summary
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Detailed description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Interventions
DRUGNB-002
DRUGVehicle control
Sponsors
NanoBio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* are healthy males or females between the ages of 18 and 75 years of age; * have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement; * positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail; * refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator; * are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Exclusion criteria
* females who are pregnant, plan to become pregnant during the study, or are nursing a child; * are hypersensitive to topical creams, ointments, medications, or surfactants; * have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or * have taken any investigational drug within 4 weeks prior to the start of the study. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Planimetry assessment of the target great toenail | Week 24 |
| Rate of complete cure | Week 46 |
| Rate of therapeutic success | Week 46 |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's visual assessment of length of new unaffected nail | — |
| The presence/absence of DSO on all toenails | — |
Countries
Canada, United States
Outcome results
None listed