## Protocol Section
### Identification Module
**NCT ID:** NCT06417983

**Acronym:** NailFungus

**Brief Title:** Topical Application of Essential Oils to Treat Onchomycosis

**Official Title:** Use of Topical Essential Oil Compound to Treat Toe Nail Onychomycosis

#### Organization Study ID Info
**ID:** Onychomycosis Topical
#### Organization
**Class:** OTHER
**Full Name:** Medical Life Care Planners, LLC
### Status Module
#### Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical Life Care Planners, LLC

#### Responsible Party

**Investigator Affiliation:** Medical Life Care Planners, LLC

**Investigator Full Name:** Gregory L Smith, MD, MPH

**Investigator Title:** Principal Investigaor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Onychomycosis of Toenail

- Fungal Infection

- Toenail Infection

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in Thickness of the Hyponychium Fungal Infection

**Time Frame:** 12 weeks

**Description:** 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.

**Measure:** Subject Perceived Improvement in overall toenail infection

**Time Frame:** 12 weeks

### Eligibility Module

**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

-

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** disabilityevaluators@gmail.com

**Name:** Andronica Handie, DPM

**Phone:** 9189944000

**Role:** CONTACT

**Contact 2:**

**Email:** DrSmith@NeX-Therapeutics.com

**Name:** Gregory L Smith

**Phone:** 4044514045

**Role:** CONTACT

### IPD Sharing Statement Module

**Access Criteria:** Researcher with clear need to know

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** 6 months

**URL:** http://nex-therapeutics.com

### References Module

#### 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.

**PMID:** 26481920

**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.

**PMID:** 28040821

**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.

**PMID:** 32076805

**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.

**PMID:** 33669627

**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.

**PMID:** 25547349

**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.

**PMID:** 33672633

**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.

**PMID:** 1303075

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000014005

- Term: Tinea

- ID: D000003881

- Term: Dermatomycoses

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000009260

- Term: Nail Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M12136

- Name: Mycoses

- Relevance: HIGH

- As Found: Fungal Infections

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M16766

- Name: Onychomycosis

- Relevance: HIGH

- As Found: Onychomycosis

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M16762

- Name: Tinea

- Relevance: LOW

- As Found: Unknown

- ID: M7076

- Name: Dermatomycoses

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M12211

- Name: Nail Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000009181

- Term: Mycoses

- ID: D000014009

- Term: Onychomycosis

### Misc Info Module

- Version Holder: 2024-05-31
