Terbinafine Compared to Griseofulvin in Children With Tinea Capitis (NCT00117767) | Clinical Trial Compass
CompletedPhase 3
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
United States720 participantsStarted 2004-06
Plain-language summary
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
* Male or female patients who are at least 4 years old and no more than 12 years old.
Exclusion Criteria:
* Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
* Patients receiving medication that may interfere with the evaluation of the drug's effect
* Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
* Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
* Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments \[e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products\] within 1 week of screening).
* Patients with a history of systemic lupus erythematosus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared terbinafine to griseofulvin specifically for tinea capitis in children — can you tell me how the complete cure rates at week 10 turned out, and whether one medication clearly performed better than the other?
2Since this was a Phase 3 trial that has already completed, does the evidence from this study change which of these two antifungal medications you would recommend for my child's tinea capitis today?
3Griseofulvin has been the traditional treatment for tinea capitis for decades — based on what this trial found, is there a reason to choose terbinafine over griseofulvin for my child's specific case, or would you still recommend the older standard treatment?
4Both terbinafine and griseofulvin require weeks of treatment — based on the 10-week timeframe used in this study, what should we realistically expect in terms of how long treatment will take and how we'll know if it's working?
5Are there any side effects or safety concerns specific to either terbinafine or griseofulvin in children that this trial's results help clarify, and how would those affect which option you'd recommend for my child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete cure (negative mycology and clinical cure) rate at Week 10