NCT06417983

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 23, 2024

Last Update Submit

May 15, 2024

Conditions

Onychomycosis of ToenailFungal InfectionToenail Infection

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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 -

You may not qualify if:

  • Unwlling to discontinue current anti-fungal medication, oral or topical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 26481920BACKGROUND

  • 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.

    PMID: 28040821BACKGROUND

  • 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.

    PMID: 32076805BACKGROUND

  • 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.

    PMID: 33669627BACKGROUND

  • 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.

    PMID: 25547349BACKGROUND

  • 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.

    PMID: 33672633BACKGROUND

  • 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.

    PMID: 1303075BACKGROUND

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Central Study Contacts

Andronica Handie, DPM

CONTACT

9189944000disabilityevaluators@gmail.com

Gregory L Smith

CONTACT

4044514045DrSmith@NeX-Therapeutics.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigaor

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 16, 2024

Study Start

May 30, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months
Access Criteria
Researcher with clear need to know
More information