- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00117754
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
Study Overview
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
- Male or female patients who are at least 4 years old and no more than 12 years old.
Exclusion Criteria:
- Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
- Patients receiving medication that may interfere with the evaluation of the drug's effect
- Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
- Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
- Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments [e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products] within 1 week of screening).
- Patients with a history of systemic lupus erythematosus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Complete cure (negative mycology and clinical cure) rate at Week 10
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Secondary Outcome Measures
Outcome Measure |
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Clinical cure rate at Week 10
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Mycological cure rate at Week 10
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Safety of terbinafine
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFO327C2302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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