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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117767
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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 or disease Intervention/treatment Phase
Tinea Capitis Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Study Start Date : June 2004
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Clinical cure rate at Week 10
  2. Mycological cure rate at Week 10
  3. Safety of terbinafine

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117767

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United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117767    
Other Study ID Numbers: CSFO327C2301
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Terbinafine, Tinea capitis, pediatric, antifungal
Additional relevant MeSH terms:
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Tinea Capitis
Bacterial Infections and Mycoses
Skin Diseases, Infectious
Skin Diseases
Scalp Dermatoses
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action