Tinea CapitisNCT07068256
Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children.
A study testing Terbinafine and Itraconazole in people with Tinea Capitis, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in… Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Terbinafine and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any gender
- Aged 1-13 years
- With KOH mount positive before start of treatment
- Duration of disease more than 1 month
Who cannot join
- KOH mount negative before starting the treatment
- Topical treatment with antifungal agents within past 4 weeks
- Systemic treatment with antifungal agents within past 4 weeks
- Patients with active liver disease
- Patients with elevated liver enzymes
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Jinnah Hospital/Allama Iqbal Medical College
Lahore, Punjab Province, 54700
About this study
Official title: Comparison Between Therapeutic Efficacy of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Pediatric Population.
Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in children with tinea capitis.
Read the detailed description
The existing literature carries varying results between the effectiveness of itraconazole pulse therapy and continuous terbinafine therapy in treating tinea capitis, and local data in this regard is also scarce. The findings of this study would not only add to the statistics but would also help clinicians to offer a treatment modality in pediatric tinea capitis, which should have better efficacy, a low incidence of side effects, and better patient compliance.
- Conditions
- Tinea Capitis
- Being tested
- Terbinafine, Itraconazole
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbinafineDrug
Terbinafine will be given at a dose of 62.5 mg in patients with a body weight < 20 kg, 125 mg from 20 to 40 kg, and 250 mg in > 40 kg for a period of 4 weeks.
ItraconazoleDrug
Itraconazole will be given at a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine group | Experimental | Patients will be given terbinafine in a dose of 62.5 mg for less than 20 kg body weight, 125 mg from 20 to 40 kg, and 250 mg for more than 40 kg for a period of 4 weeks. Receives: Drug: Terbinafine |
| Itraconazole group | Experimental | Patients will receive itraconazole a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients of this group. Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fungus eradication
Treatment will be labeled efficacious if the patient will be cured clinically as well as mycologically, i.e., samples treated with KOH will show no fungal elements.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Saima Aslam, Principal investigator, Jinnah Hospital/Allama Iqbal Medical College, LahoreFahad Iqbal, FCPS, Study director, Sir Ganga Ram Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068256
- Sponsor's protocol ID
- DRSAIMA-JHLAHORE
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Therapeutic Efficacy of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Pediatric Population.
- ClinicalTrials.gov ID
- NCT07068256
- Acronym / sponsor ID
- DRSAIMA-JHLAHORE
- Conditions
- Tinea Capitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in children with tinea capitis.
Detailed description
The existing literature carries varying results between the effectiveness of itraconazole pulse therapy and continuous terbinafine therapy in treating tinea capitis, and local data in this regard is also scarce. The findings of this study would not only add to the statistics but would also help clinicians to offer a treatment modality in pediatric tinea capitis, which should have better efficacy, a low incidence of side effects, and better patient compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine group | Experimental | Drug: TerbinafinePatients will be given terbinafine in a dose of 62.5 mg for less than 20 kg body weight, 125 mg from 20 to 40 kg, and 250 mg for more than 40 kg for a period of 4 weeks. |
| Itraconazole group | Experimental | Drug: ItraconazolePatients will receive itraconazole a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients of this group. |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Any gender
- Aged 1-13 years
- With KOH mount positive before start of treatment
- Duration of disease more than 1 month
Key exclusion criteria (5 listed)
- KOH mount negative before starting the treatment
- Topical treatment with antifungal agents within past 4 weeks
- Systemic treatment with antifungal agents within past 4 weeks
- Patients with active liver disease
- Patients with elevated liver enzymes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerbinafineTerbinafine will be given at a dose of 62.5 mg in patients with a body weight < 20 kg, 125 mg from 20 to 40 kg, and 250 mg in > 40 kg for a period of 4 weeks. | Drug | Terbinafine group |
| ItraconazoleItraconazole will be given at a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients. | Drug | Itraconazole group |
Primary outcome
Fungus eradication
Time frame: 9 weeks
Treatment will be labeled efficacious if the patient will be cured clinically as well as mycologically, i.e., samples treated with KOH will show no fungal elements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request
Related trials for Tinea Capitis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children
Fungal Infection by Site, Tinea Capitis
Recruiting
Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children
Tinea Capitis
RecruitingObservational study
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Tinea Capitis
Active, not recruitingPhase 2/3
Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working
Tinea Capitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saima Aslam principal investigator
Jinnah Hospital/Allama Iqbal Medical College, Lahore
Fahad Iqbal, FCPS study director
Sir Ganga Ram Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terbinafine and Itraconazole in people with Tinea Capitis, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fungus eradication (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.