Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05777525 |
| Other study ID # |
CreamAAT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2023 |
| Est. completion date |
November 15, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University of Extremadura |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
