search
Back to results

Use of Essential Oils as Natural Therapies

Primary Purpose

Dermatophytoses, Skin Lesion

Status
Recruiting
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
application of cream "La Chinata"
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatophytoses focused on measuring Echography, essential oils, dermatophytosis, natural treatment, ultrasonography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: who is in the age range consent signature accepted not have allergies to the treatment not have chronic skin diseases Exclusion Criteria: not meet any inclusion criteria

Sites / Locations

  • Raquel Mayordomo AcevedoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Arm Label

Echography

"Visiopor PP-34 camera"

Mycological culture

treatment application

Arm Description

Ultrasound skin measurements will be taken before and after the enriched cream treatment.

Measurements of the skin will be taken by "Visiopor PP-34" camera before and after the treatment with enriched cream.

Skin samples will be taken and analyzed by mycological culture before and after treatment with enriched cream

The essential oil enriched cream will be applied to study participants.

Outcomes

Primary Outcome Measures

Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained
Data collection with Visiopor camera. Measurement unit: occupied area
Skin thickness measured in millimeters through images obtained by ultrasound
Data collection with ultrasound. Measurement unit: millimeters
Taking mycological samples for subsequent cultivation on saboureaud agar
take mycological samples to check for infection. Measurement unit: positive/negative

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
July 4, 2023
Sponsor
University of Extremadura
search

1. Study Identification

Unique Protocol Identification Number
NCT05777525
Brief Title
Use of Essential Oils as Natural Therapies
Official Title
Use of Essential Oils as Natural Therapies Against Dermatophytosis and New Diagnostic Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Mycosis is defined as a fungal infection caused by the implantation of etiological agents that compromises the dermis and subcutaneous tissue. Dermatophytosis is a fungal infection caused by dermatophytes, being the main cause of superficial mycoses and constituting an important public health problem. The production or development of infections is due in any case to the loss of ability to protect the exterior of the skin epidermis and, in the case of nails, to the fact that the nail apparatus does not have cell-mediated immunity effective, thus being more susceptible to infection than other parts of the skin. Although these infections can be bacterial, fungal, or viral, the investigators will focus on fungal infections. There are numerous studies that suggest the suitability of EOs as an alternative treatment for fungal infections. Due to this, in this project the investigators will analyze one of the most important infections within the podiatric health of the population, in terms of its incidence, pathogenesis, diagnostic methods, etc., and for this our research will be focused on examining whether there is improvements in the skin of patients with dermatophytosis treated with cream enriched with natural oils, in our case tea tree oil, verified by ultrasound.
Detailed Description
Mycosis is defined as a fungal infection caused by the implantation of etiological agents that compromise the dermis and subcutaneous tissue. The etiological agents can be filamentous fungi, yeasts and mold fungi, present in nature, in the soil, vegetation and in decomposing organic matter. Mycosis is among the most common form of infection in humans, with an approximate incidence of 20-25% of the world population. Dermatophytosis is the fungal infection caused by dermatophytes, being the main cause of superficial mycoses and constituting an important public health problem. Dermatophytes are divided into three genera, having an affinity for and the ability to grow in keratinized tissues, such as hair, skin, and nails. Other fungal infections of the skin and appendages in humans may be caused by non-dermatophyte fungi, such as yeasts and mold fungi. Onychomycosis is dermatophytosis that affects the nails, this being one of the most frequent causes in the clinic, both in the dermatological field and in general medicine. In this type of infections, the most important thing is to know the agent that causes the infection, thus being able to establish a specific treatment. Currently, approximately 90% of toenail onychomycosis and 75% of all nail onychomycosis are caused by dermatophytes. The production or development of infections is due in any case to the loss of ability to protect the exterior of the skin epidermis and, in the case of nails, to the fact that the nail apparatus does not have cell-mediated immunity effective, thus being more susceptible to infection than other parts of the skin. Although these infections can be bacterial, fungal, or viral, the investigators will focus on fungal infections. Various scientific articles have verified and confirmed that superficial fungal infection (tinea pedis, athlete's foot, tinea versicolor, etc.) is usually referred to the foot, due to its transmission through showers and shared materials, environmental humidity , etc. There are numerous studies that suggest the suitability of EOs as an alternative treatment for fungal infections and the investigators found numerous studies that demonstrate the antifungal action of various commercial EOs in in vitro studies. Among the most studied EOs due to their antifungal activity, the following stand out: thyme (Thymus vulgaris), cinnamon (Cinnamomun zeylanicum) and tea tree (Melaleuca alternifolia), among many others. Due to this, in this project we will analyze one of the most important infections within the podiatric health of the population, in terms of its incidence, pathogenesis, diagnostic methods, etc., and for this our research will be focused on examining whether there is improvements in the skin of patients with dermatophytosis treated with cream enriched with natural oils, in our case tea tree oil, verified by ultrasound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatophytoses, Skin Lesion
Keywords
Echography, essential oils, dermatophytosis, natural treatment, ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Parallel treatment design and double-blind
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Echography
Arm Type
No Intervention
Arm Description
Ultrasound skin measurements will be taken before and after the enriched cream treatment.
Arm Title
"Visiopor PP-34 camera"
Arm Type
No Intervention
Arm Description
Measurements of the skin will be taken by "Visiopor PP-34" camera before and after the treatment with enriched cream.
Arm Title
Mycological culture
Arm Type
No Intervention
Arm Description
Skin samples will be taken and analyzed by mycological culture before and after treatment with enriched cream
Arm Title
treatment application
Arm Type
Experimental
Arm Description
The essential oil enriched cream will be applied to study participants.
Intervention Type
Combination Product
Intervention Name(s)
application of cream "La Chinata"
Intervention Description
application of cream enriched with essential oil
Primary Outcome Measure Information:
Title
Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained
Description
Data collection with Visiopor camera. Measurement unit: occupied area
Time Frame
3 months
Title
Skin thickness measured in millimeters through images obtained by ultrasound
Description
Data collection with ultrasound. Measurement unit: millimeters
Time Frame
3 months
Title
Taking mycological samples for subsequent cultivation on saboureaud agar
Description
take mycological samples to check for infection. Measurement unit: positive/negative
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: who is in the age range consent signature accepted not have allergies to the treatment not have chronic skin diseases Exclusion Criteria: not meet any inclusion criteria
Facility Information:
Facility Name
Raquel Mayordomo Acevedo
City
Plasencia
State/Province
Cáceres
ZIP/Postal Code
10600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Mayordomo Acevedo, Dr.
Phone
+03492757000
Ext
52113
Email
rmayordo@unex.es
First Name & Middle Initial & Last Name & Degree
Julia Villar Rodríguez
Phone
+034667984522
Email
juliavr@unex.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Essential Oils as Natural Therapies

We'll reach out to this number within 24 hrs