Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00117754
First received: June 30, 2005
Last updated: February 20, 2007
Last verified: August 2006
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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: July 2004
Estimated Study Completion Date: April 2006
  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: NCT00117754

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00117754     History of Changes
Other Study ID Numbers: SFO327C2302
Study First Received: June 30, 2005
Last Updated: February 20, 2007
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Institutional Review Board
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council

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

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

ClinicalTrials.gov processed this record on July 22, 2014