[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596294":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":13,"id":53,"slug":13,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":13,"maxAge":13,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":13,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":75,"whyStopped":13,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Istanbul Medeniyet University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Up to 12 weeks (until mycological cure is achieved)",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","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\u002For culture) will be enrolled.\n\nThe 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.\n\nEligible 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.\n\nStatistical analyses will include descriptive statistics, McNemar's test to assess pre\u002Fpost-treatment trichoscopic changes, sensitivity\u002Fspecificity\u002FPPV\u002FNPV 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.\n\nAll 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.","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\u002For 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.",[20],{"name":21,"affiliation":22,"role":23},"Vefa Aslı Erdemir, Proffesor","medeniyet university","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":13,"email":29},"tunç özen, MD","CONTACT","+905389515911","tuncozen1@hotmail.com",{"name":21,"role":27,"phone":31,"phoneExt":13,"email":32},"+905052685651","vefaaslı@hotmail.com",[34],{"facility":35,"status":13,"city":36,"state":37,"zip":38,"country":39,"countryCode":13,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Medeniyet University","Istanbul","Kadıköy","34728","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],28.94966,41.01384,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":13,"phoneExt":13,"email":29},"tunnç özen, MD",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Tunç Ozen","Principal Investigator","100596294",false,"NCT07043582","Trichoscopic Predictors of Treatment Response in Tinea Capitis: A Prospective Study","Tinea Capitis Patients: The Predictive Value of Trichoscopic Findings for Treatment Response - A Prospective Observational Study","TCTREP","Inclusion Criteria:\n\n* Age between 0 and 18 years\n\nClinical and trichoscopic findings compatible with tinea capitis\n\nLaboratory confirmation of tinea capitis (positive potassium hydroxide \\[KOH\\] smear and\u002For fungal culture)\n\nEligible for systemic antifungal treatment with terbinafine\n\nWritten informed consent obtained from a parent or legal guardian\n\nExclusion Criteria:\n\n* Age over 18 years\n\nNegative KOH smear and negative culture\n\nCurrent use of immunosuppressive therapy or presence of severe systemic illness (e.g., malignancy, HIV, organ transplant)\n\nContraindication to terbinafine treatment\n\nPoor compliance or unwillingness to attend follow-up visits\n\nCoexisting dermatologic conditions in the affected scalp area (e.g., seborrheic dermatitis, alopecia areata, lichen planus)","ALL",{"count":62,"type":63},150,"ESTIMATED","1 Month","OBSERVATIONAL","Brief Summary (Plain Language Version)\n\nThe 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:\n\nDo changes in trichoscopic findings show when the fungal infection is cured?\n\nDoes having more severe trichoscopic findings at the start mean that treatment will take longer or be less successful?\n\nDo different fungus types respond differently to the same treatment?\n\nParticipants will:\n\nBe between the ages of 0 and 18 with confirmed tinea capitis based on lab tests (microscopy and\u002For culture)\n\nReceive an oral antifungal medicine called terbinafine for 4 weeks (dosing based on weight)\n\nAttend regular checkups every 4 weeks until both scalp appearance and lab tests show the infection is gone\n\nAt each visit, participants will:\n\nHave their scalp examined using a trichoscope\n\nProvide scalp samples for fungal testing\n\nBe assessed for symptoms like itching, redness, and scaling\n\nThe 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.",[68],"Tinea Capitis",[70,71,72,73,74],"tinea capitis","dermotoscopy","trichoscopy","wood lamp","mycology","NOT_YET_RECRUITING","2025-06-27",{"date":78,"type":79},"2025-06-29","ACTUAL",{"date":81,"type":63},"2025-07-24",{"date":83,"type":63},"2025-10-10",{"name":5,"class":6},1]