Fungal Infection, Onychomycosis of Toenail, Toenail Infection
Conditions
Brief summary
Patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils.
Detailed description
The topical lacquer contains the following components: Active ingredients: Hydroxypropyl Chitosan OLEOZON(r) - natural, ozonized sunflower oil. Vitamin E Tea Tree Oil Cannabidiol Vehicle: Nanoparticle medium chain triglyceride oil
Interventions
None listed
Sponsors
Medical Life Care Planners, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinician observation consistent with probable onychomycosis of one or more toenails. Positive polymerase chain reaction (PCR) for fungal infection or Positive Periodic Acid Schiff, Biopsy, KOH or Culture for fungal infection -
Exclusion criteria
Unwlling to discontinue current anti-fungal medication, oral or topical \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thickness of the Hyponychium Fungal Infection | 12 weeks | Objective change in the thickness of the hyponychium of the most infected nailplate. The hyponycium will be measured with a micometer thickness guage in micrometer gradations at baseline, 2,5,9 and 12 weeks. |
| Subject Perceived Improvement in overall toenail infection | 12 weeks | Subject's personal perception of improvement of all infected toenails using the OnyCOE-t questionnaire for patient reported outcomes for toenail onychomycosis at baseline, 2,5 ,9 and 12 weeks of treatment. |
Contacts
Primary ContactAndronica Handie, DPM
Backup ContactGregory L Smith
Outcome results
None listed