Use of Essential Oils as Natural Therapies

Sponsor
University of Extremadura (Other)
Overall Status
Recruiting
CT.gov ID
NCT05777525
Collaborator
(none)
45
1
4
9.6
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: application of cream "La Chinata"
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Parallel treatment design and double-blindParallel treatment design and double-blind
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Use of Essential Oils as Natural Therapies Against Dermatophytosis and New Diagnostic Techniques
Actual Study Start Date :
Feb 11, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Echography

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

No Intervention: "Visiopor PP-34 camera"

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

No Intervention: Mycological culture

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

Experimental: treatment application

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

Combination Product: application of cream "La Chinata"
application of cream enriched with essential oil

Outcome Measures

Primary Outcome Measures

  1. Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained [3 months]

    Data collection with Visiopor camera. Measurement unit: occupied area

  2. Skin thickness measured in millimeters through images obtained by ultrasound [3 months]

    Data collection with ultrasound. Measurement unit: millimeters

  3. Taking mycological samples for subsequent cultivation on saboureaud agar [3 months]

    take mycological samples to check for infection. Measurement unit: positive/negative

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Raquel Mayordomo Acevedo Plasencia Cáceres Spain 10600

Sponsors and Collaborators

  • University of Extremadura

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ana María Pérez Pico, Clinical Professor, University of Extremadura
ClinicalTrials.gov Identifier:
NCT05777525
Other Study ID Numbers:
  • CreamAAT
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Ana María Pérez Pico, Clinical Professor, University of Extremadura
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023