Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
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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
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Tinea Capitis | Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 720 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- Complete cure (negative mycology and clinical cure) rate at Week 10
- Clinical cure rate at Week 10
- Mycological cure rate at Week 10
- Safety of terbinafine

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117767
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00117767 |
Other Study ID Numbers: |
CSFO327C2301 |
First Posted: | July 8, 2005 Key Record Dates |
Last Update Posted: | May 31, 2017 |
Last Verified: | May 2017 |
Terbinafine, Tinea capitis, pediatric, antifungal |
Tinea Tinea Capitis Dermatomycoses Mycoses Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Skin Diseases |
Scalp Dermatoses Terbinafine Griseofulvin Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |