Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hallux, Inc.
Open label, single-site
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and females 18 - 74 years of age inclusive
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit
You may not be if
History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
Significant confounding conditions as assessed by the study doctor
Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
Tinea pedis (athlete's foot) that would require systemic treatment
Clareo Health | Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
