DermatophytosisNCT07270471
Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples.
An observational study of Dermatophytosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatophytosis
- What is being tested?
- PCR dermatophyte
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 27 Dec 2024to 20 Nov 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting at CHRU Nancy for suspected dermatophyte infection.
Who may be able to join
- Patients consulting at CHRU Nancy for suspected dermatophyte infection.
Who cannot join
- out CHRU Nancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples
Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). However, diagnosing this fungal infection is challenging due to its lack of specificity and the long culture turnaround time (up to one month). A molecular approach could overcome these two limitations.
Currently, upon sample receipt, a direct mycological examination is performed alongside culture on specific media. If culture is positive, species or genus identification is carried out. Thus, the current reference method is a positive direct examination and/or a positive dermatophyte culture. Over the past four years (2020-2023), 49.85% of samples analyzed in our laboratory were positive (direct exam ± culture).
Read more
Several PCR kits are available for molecular detection of dermatophytes in skin and keratinous samples, and initial studies report promising performance: sensitivity ranging from 78.5% to 96.5% and specificity from 89.1% to 100%.
The study aims to determine the role of molecular diagnostics in these mycodermatological conditions and to compare the performance of two commercial kits.
Primary objective:
Determine the diagnostic performance of two molecular techniques for detecting dermatophytes.
The reference technique (gold standard) will be the presence of dermatophytes established by direct fungal examination. If the direct examination is negative, fungal culture will be performed for confirmation.
Secondary objectives:
Compare the diagnostic performance of the two molecular biology kits. Compare the average turnaround time for results.
- Conditions
- Dermatophytosis
- Being tested
- PCR dermatophyte
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR dermatophyteDiagnostic test
multiplex dermatophytes PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
dermatophytes : yes / no and species involved
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start27 Dec 2024
- Primary completion1 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatophytosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne DEBOURGOGNE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270471
- Sponsor's protocol ID
- 2024-PI-081
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples
- ClinicalTrials.gov ID
- NCT07270471
- Acronym / sponsor ID
- 2024-PI-081
- Conditions
- Dermatophytosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 8 Dec 2025 (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.
Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). However, diagnosing this fungal infection is challenging due to its lack of specificity and the long culture turnaround time (up to one month). A molecular approach could overcome these two limitations.
Currently, upon sample receipt, a direct mycological examination is performed alongside culture on specific media. If culture is positive, species or genus identification is carried out. Thus, the current reference method is a positive direct examination and/or a positive dermatophyte culture. Over the past four years (2020-2023), 49.85% of samples analyzed in our laboratory were positive (direct exam ± culture).
Several PCR kits are available for molecular detection of dermatophytes in skin and keratinous samples, and initial studies report promising performance: sensitivity ranging from 78.5% to 96.5% and specificity from 89.1% to 100%.
The study aims to determine the role of molecular diagnostics in these mycodermatological conditions and to compare the performance of two commercial kits.
Primary objective:
Determine the diagnostic performance of two molecular techniques for detecting dermatophytes.
The reference technique (gold standard) will be the presence of dermatophytes established by direct fungal examination. If the direct examination is negative, fungal culture will be performed for confirmation.
Secondary objectives:
Compare the diagnostic performance of the two molecular biology kits. Compare the average turnaround time for results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting at CHRU Nancy for suspected dermatophyte infection.
Key inclusion criteria (1 listed)
- Patients consulting at CHRU Nancy for suspected dermatophyte infection.
Key exclusion criteria (1 listed)
- out CHRU Nancy
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 |
|---|---|---|
| PCR dermatophytemultiplex dermatophytes PCR | Diagnostic test | – |
Primary outcome
dermatophytes : yes / no and species involved
Time frame: 1 month
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 9 Dec 2025.
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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?
An observational study of Dermatophytosis, run by Central Hospital, Nancy, France at 1 site in France.
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 1 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 9 Dec 2025. 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 France. 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.
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?
dermatophytes : yes / no and species involved (time frame: 1 month). 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 9 Dec 2025.