A Phase 4 interventional study of Fluconazole. and Terbinafine. in Tinea Capitis, sponsored by Dr. Amara Safdar. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Dr. Amara Safdar · Phase 4, Interventional, and Treatment
This open-label randomised controlled trial compared four weeks of oral fluconazole with oral terbinafine in children aged 2-10 years with KOH-confirmed tinea capitis at Allied Hospital II, Faisalabad, Pakistan. Sixty-four children were randomised equally to the two groups. The primary outcome was composite cure at week 6, defined as a Total Signs and Symptoms Score of 1 or less with negative KOH microscopy. The trial was registered retrospectively.
Children aged 2-10 years with clinically suspected, KOH-confirmed tinea capitis were allocated by lottery to oral fluconazole suspension 5 mg/kg once daily or oral terbinafine by weight band (62.5 mg/day under 20 kg; 125 mg/day for 20-40 kg) for four weeks. All children also used ketoconazole 2% shampoo twice weekly for four weeks. Clinical severity was scored at baseline and weeks 2, 4 and 6 using the Total Signs and Symptoms Score (erythema, scaling and pruritus, each 0-3). KOH microscopy was performed at baseline and week 6 by laboratory staff unaware of allocation. Liver function tests were performed at baseline and week 4, and adverse events were recorded at each visit.
Terbinafine was given by weight band to all participants rather than the 5 mg/kg/day stated in the original protocol. The trial was registered retrospectively because the investigators were unaware of the prospective registration requirement at the time.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's enrollment of 64 is close to the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →Dr. Amara Safdar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral fluconazole suspension (50 mg/5 mL) 5 mg/kg once daily for 4 weeks, plus ketoconazole 2% shampoo twice weekly for 4 weeks.
Drug: Fluconazole. · Drug: Ketoconazole 2% shampoo
Oral terbinafine 125 mg tablets by weight band (62.5 mg/day under 20 kg; 125 mg/day for 20-40 kg), crushed and mixed in water, once daily for 4 weeks, plus ketoconazole 2% shampoo twice weekly for 4 weeks.
Drug: Terbinafine. · Drug: Ketoconazole 2% shampoo
Oral suspension 5 mg/kg once daily for 4 weeks fluconazole arm
Weight-band dosing once daily for 4 weeks. Arm: Terbinafine.
Applied to the scalp twice weekly for 4 weeks. Arms: both.
Composite cure
Proportion of children with Total Signs and Symptoms Score ≤1 (erythema, scaling and pruritus, each graded 0-3) and negative KOH microscopy.
Time frame: Week 6
Clinical cure:
proportion with TSSS ≤1.
Time frame: Week 6
KOH negativity
proportion with negative KOH microscopy.
Time frame: Week 6
Change in TSSS
TSSS (range 0-9). Baseline and weeks 2, 4 and 6.
Time frame: Weeks 2, 4 and 6.
Adverse events
number of children with adverse events and abnormal liver function tests.
Time frame: Week 0 to 4 and 6
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available by the principal investigator on reasonable request.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Jun 2026, 6 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Dr. Amara Safdar