Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 3:09 AM
Study NCT ID:
NCT00117767
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014006', 'term': 'Tinea Capitis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012536', 'term': 'Scalp Dermatoses'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077291', 'term': 'Terbinafine'}, {'id': 'D006118', 'term': 'Griseofulvin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'statusVerifiedDate': '2017-05', 'lastUpdateSubmitDate': '2017-05-28', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete cure (negative mycology and clinical cure) rate at Week 10'}], 'secondaryOutcomes': [{'measure': 'Clinical cure rate at Week 10'}, {'measure': 'Mycological cure rate at Week 10'}, {'measure': 'Safety of terbinafine'}]}, 'conditionsModule': {'keywords': ['Terbinafine, Tinea capitis, pediatric, antifungal'], 'conditions': ['Tinea Capitis']}, 'referencesModule': {'references': [{'pmid': '18378354', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTerbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.\n* Male or female patients who are at least 4 years old and no more than 12 years old.\n\nExclusion Criteria:\n\n* Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)\n* Patients receiving medication that may interfere with the evaluation of the drug's effect\n* Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics\n* 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\n* 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).\n* Patients with a history of systemic lupus erythematosus"}, 'identificationModule': {'nctId': 'NCT00117767', 'briefTitle': 'Terbinafine Compared to Griseofulvin in Children With Tinea Capitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis', 'orgStudyIdInfo': {'id': 'CSFO327C2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Terbinafine', 'interventionNames': ['Drug: Terbinafine hydrochloride (HCl)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Griseofulvin', 'interventionNames': ['Drug: Griseofulvin']}], 'interventions': [{'name': 'Terbinafine hydrochloride (HCl)', 'type': 'DRUG', 'otherNames': ['Lamisil'], 'description': 'Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration', 'armGroupLabels': ['1']}, {'name': 'Griseofulvin', 'type': 'DRUG', 'otherNames': ['Grilfulvin V'], 'description': 'Griseofulvin pediatric suspension o.d. administration', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}