Use of Essential Oils as Natural Therapies

NCT05777525 | Completed Phase 3 DMC

• 1 other identifier: CreamAAT
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatophytoses; Skin Lesion

Keywords

Echography; essential oils; dermatophytosis; natural treatment; ultrasonography

Outcome Measures

Primary Outcomes (3)

• 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

  3 months

• Skin thickness measured in millimeters through images obtained by ultrasound

  Data collection with ultrasound. Measurement unit: millimeters

  3 months

• Taking mycological samples for subsequent cultivation on saboureaud agar

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

  3 months

Study Arms (4)

Echography

NO INTERVENTION

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

"Visiopor PP-34 camera"

NO INTERVENTION

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

Mycological culture

NO INTERVENTION

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

treatment application

EXPERIMENTAL

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

Combination Product: application of cream "La Chinata"

Interventions

application of cream "La Chinata" COMBINATION_PRODUCT

application of cream enriched with essential oil

treatment application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• who is in the age range
• consent signature accepted
• not have allergies to the treatment
• not have chronic skin diseases

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Raquel Mayordomo Acevedo

Plasencia, Cáceres, 10600, Spain

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Parallel treatment design and double-blind

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 21, 2023
• Study Start: February 11, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)