Topical Application of Essential Oils to Treat Onchomycosis

NCT ID: NCT06417983

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-11-01

Brief Summary

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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

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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

Conditions

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Onychomycosis of Toenail Fungal Infection Toenail Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Life Care Planners, LLC

OTHER

Sponsor Role lead

Responsible Party

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Gregory L Smith, MD, MPH

Principal Investigaor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Andronica Handie, DPM

Role: CONTACT

9189944000

Gregory L Smith

Role: CONTACT

4044514045

References

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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.

Reference Type BACKGROUND
PMID: 26481920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28040821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32076805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33669627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25547349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33672633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1303075 (View on PubMed)

Other Identifiers

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Onychomycosis Topical

Identifier Type: -

Identifier Source: org_study_id

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