Tinea CapitisTCTREPNCT07043582
Trichoscopic Predictors of Treatment Response in Tinea Capitis: A Prospective Study
An observational study of Tinea Capitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary (Plain Language Version) The goal of this observational study is to learn how well changes seen under a special microscope called a trichoscope (used to look at hair and scalp) match the success of treatment in children and adolescents with a scalp fungal infection called tinea capitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tinea Capitis
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2025to 10 Feb 2026
- How long will I take part?
- 1 Month
- 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: The study population consists of pediatric patients aged 0 to 18 years with clinically and dermoscopically suspected tinea capitis, confirmed by potassium hydroxide (KOH) smear and/or fungal culture. Participants are recruited from dermatology outpatient clinics and must be eligible for systemic antifungal treatment. The study focuses on this age group as tinea capitis primarily affects children and adolescents.
Who may be able to join
- Age between 0 and 18 years
- Clinical and trichoscopic findings compatible with tinea capitis
- Laboratory confirmation of tinea capitis (positive potassium hydroxide [KOH] smear and/or fungal culture)
- Eligible for systemic antifungal treatment with terbinafine
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Age over 18 years
- Negative KOH smear and negative culture
- Current use of immunosuppressive therapy or presence of severe systemic illness (e.g., malignancy, HIV, organ transplant)
- Contraindication to terbinafine treatment
- Poor compliance or unwillingness to attend follow-up visits
- Coexisting dermatologic conditions in the affected scalp area (e.g., seborrheic dermatitis, alopecia areata, lichen planus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tinea Capitis Patients: The Predictive Value of Trichoscopic Findings for Treatment Response - A Prospective Observational Study
Brief Summary (Plain Language Version)
The goal of this observational study is to learn how well changes seen under a special microscope called a trichoscope (used to look at hair and scalp) match the success of treatment in children and adolescents with a scalp fungal infection called tinea capitis. The main questions it aims to answer are:
Read more
Do changes in trichoscopic findings show when the fungal infection is cured?
Does having more severe trichoscopic findings at the start mean that treatment will take longer or be less successful?
Do different fungus types respond differently to the same treatment?
Participants will:
Be between the ages of 0 and 18 with confirmed tinea capitis based on lab tests (microscopy and/or culture)
Receive an oral antifungal medicine called terbinafine for 4 weeks (dosing based on weight)
Attend regular checkups every 4 weeks until both scalp appearance and lab tests show the infection is gone
At each visit, participants will:
Have their scalp examined using a trichoscope
Provide scalp samples for fungal testing
Be assessed for symptoms like itching, redness, and scaling
The study will also look at how fast different signs on the scalp go away, and which of these signs are best at predicting whether the fungus is still present.
Read the detailed description
This prospective observational study aims to evaluate the predictive value of trichoscopic findings for treatment response in pediatric patients (ages 0-18) diagnosed with tinea capitis. Tinea capitis is a fungal infection of the scalp that commonly affects children. Diagnosis will be confirmed through clinical evaluation, dermoscopic examination, and laboratory testing, including potassium hydroxide (KOH) smear and fungal culture from scalp samples. Only patients with laboratory-confirmed tinea capitis (positive KOH and/or culture) will be enrolled.
The primary objective is to determine the correlation between trichoscopic changes and mycological cure, defined as both KOH and culture negativity following systemic antifungal treatment with terbinafine. Secondary objectives include evaluating the timeline of regression for individual trichoscopic signs, determining whether certain dermoscopic features persist despite microbiological cure, and assessing whether specific patterns are predictive of treatment resistance. Additionally, the study aims to investigate if baseline trichoscopic scores or fungal species (e.g., Microsporum canis, Trichophyton tonsurans, T. violaceum) are associated with prolonged treatment duration or lower cure rates.
Eligible patients will receive weight-adjusted oral terbinafine therapy for four weeks and return for clinical, trichoscopic, and microbiological evaluation every four weeks thereafter until both clinical and mycological cure are achieved. At each follow-up, standardized data will be collected including clinical symptoms (e.g., erythema, scaling, hair loss), trichoscopic features (e.g., comma hairs, corkscrew hairs, black dots), and laboratory results. Trichoscopic evaluations will be recorded using handheld dermoscopy and interpreted independently by two dermatologists. Discrepancies will be resolved by a third expert reviewer.
Statistical analyses will include descriptive statistics, McNemar's test to assess pre/post-treatment trichoscopic changes, sensitivity/specificity/PPV/NPV analyses for predicting culture positivity, and Kaplan-Meier survival analysis for the regression timing of individual dermoscopic findings. Regression models will explore predictors of treatment duration and failure. A trichoscopic scoring system will also be evaluated as a tool for estimating treatment response.
All procedures will comply with the Declaration of Helsinki, and written informed consent will be obtained from legal guardians. Patient confidentiality will be maintained throughout the study. The findings are expected to enhance early treatment monitoring and guide clinical decisions using non-invasive imaging tools.
- Conditions
- Tinea Capitis
- Keywords
- tinea capitis, dermotoscopy, trichoscopy, wood lamp, mycology
- Medical subject headings
- Tinea Capitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with disappearance of characteristic trichoscopic findings at the time of mycological cure
The primary outcome is the proportion (%) of patients who exhibit complete regression of characteristic trichoscopic findings (e.g., black dots, comma hairs, corkscrew hairs) as assessed by trichoscopic examination, at the time of mycological cure. Mycological cure is defined as negative results on both potassium hydroxide (KOH) smear and fungal culture.
Measured: Up to 12 weeks (until mycological cure is achieved)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start24 Jun 2025
- Primary completion10 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tunç Ozen, Istanbul Medeniyet University
- Investigators
- Vefa Aslı Erdemir, Proffesor, Study director, medeniyet university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043582
- Sponsor's protocol ID
- 2536854
- Acronym
- TCTREP
- Status last verified
- Jul 2026
- First submitted
- 23 May 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinea Capitis Patients: The Predictive Value of Trichoscopic Findings for Treatment Response - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07043582
- Acronym / sponsor ID
- TCTREP / 2536854
- Conditions
- Tinea Capitis
- Keywords
- tinea capitis, dermotoscopy, trichoscopy, wood lamp, mycology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 29 Jun 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.
Brief Summary (Plain Language Version)
The goal of this observational study is to learn how well changes seen under a special microscope called a trichoscope (used to look at hair and scalp) match the success of treatment in children and adolescents with a scalp fungal infection called tinea capitis. The main questions it aims to answer are:
Do changes in trichoscopic findings show when the fungal infection is cured?
Does having more severe trichoscopic findings at the start mean that treatment will take longer or be less successful?
Do different fungus types respond differently to the same treatment?
Participants will:
Be between the ages of 0 and 18 with confirmed tinea capitis based on lab tests (microscopy and/or culture)
Receive an oral antifungal medicine called terbinafine for 4 weeks (dosing based on weight)
Attend regular checkups every 4 weeks until both scalp appearance and lab tests show the infection is gone
At each visit, participants will:
Have their scalp examined using a trichoscope
Provide scalp samples for fungal testing
Be assessed for symptoms like itching, redness, and scaling
The study will also look at how fast different signs on the scalp go away, and which of these signs are best at predicting whether the fungus is still present.
Detailed description
This prospective observational study aims to evaluate the predictive value of trichoscopic findings for treatment response in pediatric patients (ages 0-18) diagnosed with tinea capitis. Tinea capitis is a fungal infection of the scalp that commonly affects children. Diagnosis will be confirmed through clinical evaluation, dermoscopic examination, and laboratory testing, including potassium hydroxide (KOH) smear and fungal culture from scalp samples. Only patients with laboratory-confirmed tinea capitis (positive KOH and/or culture) will be enrolled.
The primary objective is to determine the correlation between trichoscopic changes and mycological cure, defined as both KOH and culture negativity following systemic antifungal treatment with terbinafine. Secondary objectives include evaluating the timeline of regression for individual trichoscopic signs, determining whether certain dermoscopic features persist despite microbiological cure, and assessing whether specific patterns are predictive of treatment resistance. Additionally, the study aims to investigate if baseline trichoscopic scores or fungal species (e.g., Microsporum canis, Trichophyton tonsurans, T. violaceum) are associated with prolonged treatment duration or lower cure rates.
Eligible patients will receive weight-adjusted oral terbinafine therapy for four weeks and return for clinical, trichoscopic, and microbiological evaluation every four weeks thereafter until both clinical and mycological cure are achieved. At each follow-up, standardized data will be collected including clinical symptoms (e.g., erythema, scaling, hair loss), trichoscopic features (e.g., comma hairs, corkscrew hairs, black dots), and laboratory results. Trichoscopic evaluations will be recorded using handheld dermoscopy and interpreted independently by two dermatologists. Discrepancies will be resolved by a third expert reviewer.
Statistical analyses will include descriptive statistics, McNemar's test to assess pre/post-treatment trichoscopic changes, sensitivity/specificity/PPV/NPV analyses for predicting culture positivity, and Kaplan-Meier survival analysis for the regression timing of individual dermoscopic findings. Regression models will explore predictors of treatment duration and failure. A trichoscopic scoring system will also be evaluated as a tool for estimating treatment response.
All procedures will comply with the Declaration of Helsinki, and written informed consent will be obtained from legal guardians. Patient confidentiality will be maintained throughout the study. The findings are expected to enhance early treatment monitoring and guide clinical decisions using non-invasive imaging tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of pediatric patients aged 0 to 18 years with clinically and dermoscopically suspected tinea capitis, confirmed by potassium hydroxide (KOH) smear and/or fungal culture. Participants are recruited from dermatology outpatient clinics and must be eligible for systemic antifungal treatment. The study focuses on this age group as tinea capitis primarily affects children and adolescents.
Key inclusion criteria (5 listed)
- Age between 0 and 18 years
- Clinical and trichoscopic findings compatible with tinea capitis
- Laboratory confirmation of tinea capitis (positive potassium hydroxide [KOH] smear and/or fungal culture)
- Eligible for systemic antifungal treatment with terbinafine
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (6 listed)
- Age over 18 years
- Negative KOH smear and negative culture
- Current use of immunosuppressive therapy or presence of severe systemic illness (e.g., malignancy, HIV, organ transplant)
- Contraindication to terbinafine treatment
- Poor compliance or unwillingness to attend follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with disappearance of characteristic trichoscopic findings at the time of mycological cure
Time frame: Up to 12 weeks (until mycological cure is achieved)
The primary outcome is the proportion (%) of patients who exhibit complete regression of characteristic trichoscopic findings (e.g., black dots, comma hairs, corkscrew hairs) as assessed by trichoscopic examination, at the time of mycological cure. Mycological cure is defined as negative results on both potassium hydroxide (KOH) smear and fungal culture.
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 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Tinea Capitis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children
Fungal Infection by Site, Tinea Capitis
Recruiting
Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children
Tinea Capitis
RecruitingObservational study
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Tinea Capitis
Active, not recruitingPhase 2/3
Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working
Tinea Capitis
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.
Vefa Aslı Erdemir, Proffesor study director
medeniyet university
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 Tinea Capitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 28 Jul 2026. 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 Turkey (Türkiye). 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?
Proportion of patients with disappearance of characteristic trichoscopic findings at the time of mycological cure (time frame: Up to 12 weeks (until mycological cure is achieved)). 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 28 Jul 2026.