Clinical trial NCT06417983: Topical Application of Essential Oils to Treat Onchomycosis
Official title: Use of Topical Essential Oil Compound to Treat Toe Nail Onychomycosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Onychomycosis of Toenail
Fungal Infection
Toenail Infection
Lead sponsor: Medical Life Care Planners, LLC
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

-

Primary outcomes:
measure: Change in Thickness of the Hyponychium Fungal Infection
timeFrame: 12 weeks
measure: Subject Perceived Improvement in overall toenail infection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Flores FC, Beck RC, da Silva Cde B. Essential Oils for Treatment for Onychomycosis: A Mini-Review. Mycopathologia. 2016 Feb;181(1-2):9-15. doi: 10.1007/s11046-015-9957-3. Epub 2015 Oct 19.
citation: Halteh P, Scher RK, Lipner SR. Over-the-counter and natural remedies for onychomycosis: do they really work? Cutis. 2016 Nov;98(5):E16-E25.
citation: Wang Y, Lipner SR. Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration. Arch Dermatol Res. 2020 Oct;312(8):581-586. doi: 10.1007/s00403-020-02044-7. Epub 2020 Feb 19.
citation: Abd Rashed A, Rathi DG, Ahmad Nasir NAH, Abd Rahman AZ. Antifungal Properties of Essential Oils and Their Compounds for Application in Skin Fungal Infections: Conventional and Nonconventional Approaches. Molecules. 2021 Feb 19;26(4):1093. doi: 10.3390/molecules26041093.
citation: Ghannoum MA, Long L, Isham N, Bulgheroni A, Setaro M, Caserini M, Palmieri R, Mailland F. Ability of hydroxypropyl chitosan nail lacquer to protect against dermatophyte nail infection. Antimicrob Agents Chemother. 2015 Apr;59(4):1844-8. doi: 10.1128/AAC.04842-14. Epub 2014 Dec 29.
citation: Feldman M, Sionov RV, Mechoulam R, Steinberg D. Anti-Biofilm Activity of Cannabidiol against Candida albicans. Microorganisms. 2021 Feb 20;9(2):441. doi: 10.3390/microorganisms9020441.
citation: Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Australas J Dermatol. 1992;33(3):145-9. doi: 10.1111/j.1440-0960.1992.tb00103.x.