Tinea CapitisNCT07046988
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
An observational study of Tinea Capitis, run by Shandong University at 1 site in China.
Trial summary
The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Terbinafine Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 1 Jun 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Chinese pediatric patients aged 2 to 18 years
Who may be able to join
- Aged 2 to 18 years;
- Diagnosis of tinea capitis:
- Typical clinical manifestations, dermatoscopic findings combined with Wood's lamp examination; ② Positive mycological examination, including positive fungal microscopy and/or isolation of dermatophytes by fungal culture; ③ Exclusion of scalp seborrheic dermatitis, psoriasis, alopecia areata, lupus erythematosus, lichen planopilaris, trichotillomania, suppurative perifolliculitis of scalp, syphilitic alopecia, etc.
Who cannot join
- Concomitant topical treatment with terbinafine;
- Conditions interfering with gastrointestinal absorption of terbinafine;
- Documented hepatic/renal impairment or hematological disorders;
- Receipt of radiotherapy, systemic cytostatic/immunosuppressive therapy, or antibacterial/antiviral/antiparasitic therapy currently or within 2 weeks prior to study initiation;
- Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Weiwei Jiao, +8613811970550, jiaowei310@163.com
About this study
The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with oral terbinafine. The main questions it aims to answer are:
What are the terbinafine pharmacokinetic parameters (e.g., AUC, CL, V) in children with tinea capitis, and how do they differ from adult values? Which covariates (e.g., age, body weight, CYP enzyme activity, renal function) significantly influence inter-individual variability in terbinafine PK parameters? What is the clinical efficacy (based on TSSS reduction and mycological cure rate) and safety profile of terbinafine in this pediatric population?
Read more
Participants will:
Undergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily).
Concentration determination is carried out using the opportunistic sampling method.
Complete clinical assessments (TSSS scoring) and mycological examinations (microscopy/culture) at baseline and follow-up visits.
Undergo routine laboratory tests (liver/kidney function, hematology) to monitor safety.
- Conditions
- Tinea Capitis
- Being tested
- Terbinafine Tablets
- Keywords
- Tinea Capitis
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine TabletsDrug
Oral administration once daily:
For patients weighing <20 kg: 62.5 mg qd; For patients weighing 20-40 kg: 125 mg qd; For patients weighing >40 kg: 250 mg qd; Total 8 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Terbinafine concentration
Terbinafine plasma concentration, terbinafine concentration in hair
Measured: Through study completion, an average of 12 weeks.
AUC
Area under the curve (AUC)
Measured: Through study completion, an average of 12 weeks.
CL
Clearance (CL)
Measured: Through study completion, an average of 12 weeks.
V
Apparent volume of distribution (V)
Measured: Through study completion, an average of 12 weeks.
CV%
Inter-individual variability (CV%) of AUC, CL and V with covariates
Measured: Through study completion, an average of 12 weeks.
Secondary outcomes (4)
Clinical Efficacy
Defined as a 60-99% reduction in TSSS compared to baseline. Values below 60% are considered ineffective.
Clinical efficacy rate = (number of effective cases / total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation/scaling, papules, pustules, and pruritus) into 4 grades (0 = none; 1 = mild; 2 = moderate; 3 = severe). The sum of these scores yields TSSS, with a maximum of 15 points.
Measured: The end of fellow-up, at 12 weeks
Clinical Cure
Defined as 100% efficacy (TSSS = 0). Clinical cure rate = (number of clinically cured cases / total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation/scaling, papules, pustules, and pruritus) into 4 grades (0 = none; 1 = mild; 2 = moderate; 3 = severe). The sum of these scores yields TSSS, with a maximum of 15 points.
Measured: The end of fellow-up, at 12 weeks
Mycological Cure
Defined as negative mycological examination results. Mycological cure rate = (number of mycologically cured cases / total cases) × 100%.
Measured: The end of fellow-up, at 12 weeks
Safety Assessment Indicators
Drug-related adverse events and serious adverse events during the study.
Measured: From enrollment to the end of treatment about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046988
- Sponsor's protocol ID
- SDU-ZW-PPK-014
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
- ClinicalTrials.gov ID
- NCT07046988
- Acronym / sponsor ID
- SDU-ZW-PPK-014
- Conditions
- Tinea Capitis
- Keywords
- Tinea Capitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 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.
The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with oral terbinafine. The main questions it aims to answer are:
What are the terbinafine pharmacokinetic parameters (e.g., AUC, CL, V) in children with tinea capitis, and how do they differ from adult values? Which covariates (e.g., age, body weight, CYP enzyme activity, renal function) significantly influence inter-individual variability in terbinafine PK parameters? What is the clinical efficacy (based on TSSS reduction and mycological cure rate) and safety profile of terbinafine in this pediatric population?
Participants will:
Undergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily).
Concentration determination is carried out using the opportunistic sampling method.
Complete clinical assessments (TSSS scoring) and mycological examinations (microscopy/culture) at baseline and follow-up visits.
Undergo routine laboratory tests (liver/kidney function, hematology) to monitor safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Chinese pediatric patients aged 2 to 18 years
Key inclusion criteria (3 listed)
- Aged 2 to 18 years;
- Diagnosis of tinea capitis:
Key exclusion criteria (5 listed)
- Concomitant topical treatment with terbinafine;
- Conditions interfering with gastrointestinal absorption of terbinafine;
- Documented hepatic/renal impairment or hematological disorders;
- Receipt of radiotherapy, systemic cytostatic/immunosuppressive therapy, or antibacterial/antiviral/antiparasitic therapy currently or within 2 weeks prior to study initiation;
- Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.
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 |
|---|---|---|
| Terbinafine TabletsOral administration once daily: For patients weighing <20 kg: 62.5 mg qd; For patients weighing 20-40 kg: 125 mg qd; For patients weighing >40 kg: 250 mg qd; Total 8 weeks. | Drug | – |
Primary outcome
Terbinafine concentration
Time frame: Through study completion, an average of 12 weeks.
Terbinafine plasma concentration, terbinafine concentration in hair
AUC
Time frame: Through study completion, an average of 12 weeks.
Area under the curve (AUC)
CL
Time frame: Through study completion, an average of 12 weeks.
Clearance (CL)
V
Time frame: Through study completion, an average of 12 weeks.
Apparent volume of distribution (V)
CV%
Time frame: Through study completion, an average of 12 weeks.
Inter-individual variability (CV%) of AUC, CL and V with covariates
4 secondary outcomes
Clinical Efficacy
Time frame: The end of fellow-up, at 12 weeks
Clinical Cure
Time frame: The end of fellow-up, at 12 weeks
Mycological Cure
Time frame: The end of fellow-up, at 12 weeks
Safety Assessment Indicators
Time frame: From enrollment to the end of treatment about 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
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
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Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children
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.
Beijing Children's Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinea Capitis, run by Shandong University at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 2 Jul 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Terbinafine concentration (time frame: Through study completion, an average of 12 weeks.). The study lists 5 primary outcomes in all. 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 2 Jul 2025.