Safety and Efficacy of NAFT900 in Children With Tinea Capitis (NCT02658292) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Efficacy of NAFT900 in Children With Tinea Capitis
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Plain-language summary
A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to \< 13 Years with Tinea Capitis
Who can participate
Age range
6 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
. Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
. Subjects with positive KOH microscopy and culture \[for dermatophytes\].
. Male or female subjects ≥6 years and \<13 years of age on the date of the Baseline Visit.
Exclusion criteria
. Subject with acute inflammatory fungal infection of the scalp (kerion)
. Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis).
. Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
. Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
. Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
. Subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit.
. Subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.
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1This trial for tinea capitis in children was withdrawn before enrolling anyone — does that mean there are safety concerns with NAFT900 I should know about, or was it withdrawn for other reasons like funding or scheduling?
2Since this was only a Phase 2 trial, the evidence on how safe and effective NAFT900 is in children would still be fairly early-stage — are there better-studied antifungal treatments for my child's tinea capitis that we should consider first?
3The trial's main goal was to measure 'complete cure' — how does that compare to what we'd expect from the standard treatments available right now for my child?
4Because this trial is no longer recruiting or running, are there any other active clinical trials studying tinea capitis treatments in children that might be worth looking into?
5Given that this study was specifically designed for children, how does my child's age, weight, or severity of infection affect which treatment options are actually appropriate for them right now?
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
Compare the proportion of subjects with complete cure