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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00117767
First received: June 30, 2005
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

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
Terbinafine
Drug: Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
Other Name: Lamisil
Active Comparator: 2
Griseofulvin
Drug: Griseofulvin
Griseofulvin pediatric suspension o.d. administration
Other Name: Grilfulvin V

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117767

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

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00117767     History of Changes
Other Study ID Numbers: CSFO327C2301
Study First Received: June 30, 2005
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
South Africa: Medicines Control Council

Keywords provided by Novartis:
Terbinafine, Tinea capitis, pediatric, antifungal

Additional relevant MeSH terms:
Tinea
Tinea Capitis
Dermatomycoses
Infection
Mycoses
Scalp Dermatoses
Skin Diseases
Skin Diseases, Infectious
Terbinafine
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014