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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
This study has been completed.
First Received: June 30, 2005   Last Updated: February 20, 2007   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00117754
  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 III

MedlinePlus related topics: Tinea Infections
Drug Information available for: Terbinafine hydrochloride Terbinafine Griseofulvin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

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
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

Study ID Numbers: SFO327C2302
Study First Received: June 30, 2005
Last Updated: February 20, 2007
ClinicalTrials.gov Identifier: NCT00117754     History of Changes
Health Authority: United States: Food and Drug Administration;   Brazil: National Health Surveillance Agency;   France: Afssaps - French Health Products Safety Agency;   India: Institutional Review Board;   Russia: Pharmacological Committee, Ministry of Health;   South Africa: Medicines Control Council

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

Study placed in the following topic categories:
Skin Diseases
Clotrimazole
Miconazole
Tioconazole
Mycoses
Anti-Bacterial Agents
Skin Diseases, Infectious
Antifungal Agents
Tinea Capitis
Griseofulvin
Tinea
Dermatomycoses
Terbinafine

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

ClinicalTrials.gov processed this record on May 07, 2009