An observational study in Onychomycosis of Toenail, Fungal Infection and Toenail Infection, sponsored by Medical Life Care Planners, LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Medical Life Care Planners, LLC · Observational
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.
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
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 50 is below the median of 153 across 85 observational studies indexed under Mycoses.
Browse Mycoses studies →Medical Life Care Planners, LLC is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients presenting to a community podiatry clinic who upon examination are noted to have podiatrist diagnosed onychomycosis of one or more toenails. Not currently using topical or oral anti-fungal treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinician observation consistent with probable onychomycosis of one or more toenails.
Positive polymerase chain reaction (PCR) for fungal infection or Positive Periodic Acid Schiff, , KOH or Culture for fungal infection -
Exclusion Criteria:
Unwlling to discontinue current anti-fungal medication, oral or topical
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in Thickness of the Hyponychium Fungal Infection
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.
Time frame: 12 weeks
Subject Perceived Improvement in overall toenail infection
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.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 6 months
Access criteria: Researcher with clear need to know
Data sharing details ↗ · nex-therapeutics.com
Start is estimated for May 2024; primary completion for Nov 2024, 5 months later.
Of 28 observational studies under Mycoses, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Medical Life Care Planners, LLC