About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 0 and 18 years
Disqualifiers
Age over 18 years
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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