Trichoscopic Predictors of Treatment Response in Tinea Capitis: A Prospective Study

NCT07043582 | Not Yet Recruiting

• 1 other identifier: 2536854
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tinea Capitis

Keywords

tinea capitis; dermotoscopy; trichoscopy; wood lamp; mycology

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Medeniyet University

Istanbul, Kadıköy, 34728, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Hair shafts, scalp scales, and fungal cultures obtained from affected areas will be retained for microbiological analyses, including potassium hydroxide (KOH) examination, fungal culture, species identification, and MALDI-TOF MS analysis.

MeSH Terms

Conditions

Tinea Capitis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Scalp Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vefa Aslı Erdemir, Proffesor

  medeniyet university

  STUDY DIRECTOR

Central Study Contacts

tunç özen, MD

CONTACT

+905389515911; tuncozen1@hotmail.com

Vefa Aslı Erdemir, Proffesor

CONTACT

+905052685651; vefaaslı@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 29, 2025
• Study Start: July 24, 2025
• Primary Completion: September 10, 2025
• Study Completion: October 10, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)