Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117767
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 8, 2005
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE June 2004
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
Complete cure (negative mycology and clinical cure) rate at Week 10
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00117767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
  • Clinical cure rate at Week 10
  • Mycological cure rate at Week 10
  • Safety of terbinafine
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Official Title  ICMJE Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinea Capitis
Intervention  ICMJE
  • Drug: Terbinafine hydrochloride (HCl)
    Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
    Other Name: Lamisil
  • Drug: Griseofulvin
    Griseofulvin pediatric suspension o.d. administration
    Other Name: Grilfulvin V
Study Arms  ICMJE
  • Experimental: 1
    Terbinafine
    Intervention: Drug: Terbinafine hydrochloride (HCl)
  • Active Comparator: 2
    Griseofulvin
    Intervention: Drug: Griseofulvin
Publications * Elewski BE, Cáceres 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 18, 2006)
720
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00117767
Other Study ID Numbers  ICMJE CSFO327C2301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP