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Completed

NCT Number: NCT00117754

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

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.

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Key information

Conditions

Tinea Capitis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Scalp Dermatoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbinafine hydrochloride

Drug

Primary outcomes

  1. Complete cure (negative mycology and clinical cure) rate at Week 10

Secondary outcomes

  1. Clinical cure rate at Week 10

  2. Mycological cure rate at Week 10

  3. Safety of terbinafine

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Important dates

Study start
2004
Study completion
2006
First posted
Jul 8, 2005
Registry last updated
Feb 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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