NCT00117767

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

June 30, 2005

Last Update Submit

May 28, 2017

Conditions

Tinea Capitis

Keywords

Terbinafine, Tinea capitis, pediatric, antifungal

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Clinical cure rate at Week 10

  • Mycological cure rate at Week 10

  • Safety of terbinafine

Study Arms (2)

1

EXPERIMENTAL

Terbinafine

Drug: Terbinafine hydrochloride (HCl)

2

ACTIVE COMPARATOR

Griseofulvin

Drug: Griseofulvin

Interventions

Terbinafine hydrochloride (HCl)DRUG

Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration

Also known as: Lamisil
1
GriseofulvinDRUG

Griseofulvin pediatric suspension o.d. administration

Also known as: Grilfulvin V
2

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Elewski BE, Caceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, Sanchez-Bal V, Todd G, Wraith L, Cai B, Tavakkol A, Bakshi R, Nyirady J, Friedlander SF. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol. 2008 Jul;59(1):41-54. doi: 10.1016/j.jaad.2008.02.019. Epub 2008 Apr 18.

    PMID: 18378354BACKGROUND

MeSH Terms

Conditions

Tinea Capitis

Interventions

TerbinafineGriseofulvin

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousScalp DermatosesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 8, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2006

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

US(1)