Oral Fluconazole vs Oral Terbinafine for Tinea Capitis in Children Aged 2-10 Years
Tinea Capitis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 2 years - 10 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 64 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Children aged 2-10 years of either sex
- Patchy hair loss, scaling and pruritus of the scalp for at least one month
- Tinea capitis confirmed by KOH microscopy
- Written informed consent from a parent or legal guardian
Exclusion Criteria:
- Systemic or topical antifungal treatment within the preceding six weeks
- Known hypersensitivity to fluconazole or terbinafine
- Hepatic dysfunction on baseline liver function tests
- History of prolonged QT interval
- Immunocompromised state
- Diabetes mellitus
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Fluconazole
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
Terbinafine
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
Fluconazole. DRUG
Oral suspension 5 mg/kg once daily for 4 weeks fluconazole arm
Terbinafine. DRUG
Weight-band dosing once daily for 4 weeks. Arm: Terbinafine.
Ketoconazole 2% shampoo DRUG
Applied to the scalp twice weekly for 4 weeks. Arms: both.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Composite cure
Time frame: Week 6
Proportion of children with Total Signs and Symptoms Score ≤1 (erythema, scaling and pruritus, each graded 0-3) and negative KOH microscopy.
Secondary measures
Clinical cure:
Time frame: Week 6
proportion with TSSS ≤1.
KOH negativity
Time frame: Week 6
proportion with negative KOH microscopy.
Change in TSSS
Time frame: Weeks 2, 4 and 6.
TSSS (range 0-9). Baseline and weeks 2, 4 and 6.
Adverse events
Time frame: Week 0 to 4 and 6
number of children with adverse events and abnormal liver function tests.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Allied Hospital 2, Faisalabad Medical UniversityFaisalābad, Punjab Province, PakistanStatus unknown
Study team and timeline
- Lead sponsor
- Dr. Amara Safdar
- Study start
- Dec 1, 2025 Actual
- Primary completion
- Jun 13, 2026 Actual
- Study completion
- Jun 27, 2026 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Oral Fluconazole Versus Oral Terbinafine for Tinea Capitis in Children Aged 2-10 Years: An Open-Label Randomised Controlled Trial
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026