Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00117767
First received: June 30, 2005
Last updated: November 1, 2011
Last verified: November 2011
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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 (HCl) Drug: Griseofulvin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) 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: | June 2004 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Terbinafine
|
Drug: Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
Other Name: Lamisil
|
|
Active Comparator: 2
Griseofulvin
|
Drug: Griseofulvin
Griseofulvin pediatric suspension o.d. administration
Other Name: Grilfulvin V
|
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: NCT00117767
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117767
Locations
| United States, New Jersey | |
| Novartis Pharmaceuticals | |
| East Hanover, New Jersey, United States, 07936 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00117767 History of Changes |
| Other Study ID Numbers: | CSFO327C2301 |
| Study First Received: | June 30, 2005 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Peru: General Directorate of Pharmaceuticals, Devices, and Drugs South Africa: Medicines Control Council |
Keywords provided by Novartis:
|
Terbinafine, Tinea capitis, pediatric, antifungal |
Additional relevant MeSH terms:
|
Tinea Tinea Capitis Dermatomycoses Infection Mycoses Scalp Dermatoses Skin Diseases Skin Diseases, Infectious |
Terbinafine Anti-Infective Agents Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015