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临床试验/NCT07043582
NCT07043582已完成不适用

Tinea Capitis Patients: The Predictive Value of Trichoscopic Findings for Treatment Response - A Prospective Observational Study

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Proportion of patients with disappearance of characteristic trichoscopic findings at the time of mycological cure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Proportion of patients with disappearance of characteristic trichoscopic findings at the time of mycological cure

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tunç Ozen

Principal Investigator

Istanbul Medeniyet University

研究点 (1)

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