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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 30, 2005
Last updated: May 28, 2017
Last verified: May 2017

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.

Condition Intervention Phase
Tinea Capitis Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Complete cure (negative mycology and clinical cure) rate at Week 10

Secondary Outcome Measures:
  • Clinical cure rate at Week 10
  • Mycological cure rate at Week 10
  • Safety of terbinafine

Estimated Enrollment: 720
Study Start Date: June 2004
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
Other Name: Lamisil
Active Comparator: 2
Drug: Griseofulvin
Griseofulvin pediatric suspension o.d. administration
Other Name: Grilfulvin V


Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00117767

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00117767     History of Changes
Other Study ID Numbers: CSFO327C2301
Study First Received: June 30, 2005
Last Updated: May 28, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Terbinafine, Tinea capitis, pediatric, antifungal

Additional relevant MeSH terms:
Tinea Capitis
Skin Diseases, Infectious
Skin Diseases
Scalp Dermatoses
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on July 19, 2017