DermatophytosesPhase 3NCT05777525
Use of Essential Oils as Natural Therapies
A Phase 3 study testing application of cream "La Chinata" in people with Dermatophytoses and Skin Lesion, run by University of Extremadura at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatophytoses, Skin Lesion
- What is being tested?
- application of cream "La Chinata"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2023to 15 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- who is in the age range
- consent signature accepted
- not have allergies to the treatment
- not have chronic skin diseases
Who cannot join
- not meet any inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Essential Oils as Natural Therapies Against Dermatophytosis and New Diagnostic Techniques
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.
Read more
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.
Read the 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.
- Conditions
- Dermatophytoses, Skin Lesion
- Being tested
- application of cream "La Chinata"
- Keywords
- Echography, essential oils, dermatophytosis, natural treatment, ultrasonography
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of cream "La Chinata"Combination product
application of cream enriched with essential oil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: application of cream "La Chinata" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Skin thickness measured in millimeters through images obtained by ultrasound
Data collection with ultrasound. Measurement unit: millimeters
Measured: 3 months
Taking mycological samples for subsequent cultivation on saboureaud agar
take mycological samples to check for infection. Measurement unit: positive/negative
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start11 Feb 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatophytosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel treatment design and double-blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María Pérez Pico, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777525
- Sponsor's protocol ID
- CreamAAT
- Status last verified
- Dec 2023
- First submitted
- 13 Feb 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Essential Oils as Natural Therapies Against Dermatophytosis and New Diagnostic Techniques
- ClinicalTrials.gov ID
- NCT05777525
- Acronym / sponsor ID
- CreamAAT
- Conditions
- Dermatophytoses, Skin Lesion
- Keywords
- Echography, essential oils, dermatophytosis, natural treatment, ultrasonography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel treatment design and double-blind
| Arm | Type | Receives |
|---|---|---|
| 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 | Combination Product: application of cream "La Chinata"The essential oil enriched cream will be applied to study participants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- who is in the age range
- consent signature accepted
- not have allergies to the treatment
- not have chronic skin diseases
Key exclusion criteria (1 listed)
- not meet any inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of cream "La Chinata"application of cream enriched with essential oil | Combination product | treatment application |
Primary outcome
Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained
Time frame: 3 months
Data collection with Visiopor camera. Measurement unit: occupied area
Skin thickness measured in millimeters through images obtained by ultrasound
Time frame: 3 months
Data collection with ultrasound. Measurement unit: millimeters
Taking mycological samples for subsequent cultivation on saboureaud agar
Time frame: 3 months
take mycological samples to check for infection. Measurement unit: positive/negative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing application of cream "La Chinata" in people with Dermatophytoses and Skin Lesion, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.