Topical Application of Essential Oils to Treat Onchomycosis
- Conditions
- Fungal InfectionToenail InfectionOnychomycosis of Toenail
- Registration Number
- NCT06417983
- Lead Sponsor
- Medical Life Care Planners, LLC
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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 -
Unwlling to discontinue current anti-fungal medication, oral or topical
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method