Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-30 @ 1:07 AM
Study NCT ID:
NCT00869492
Status:
UNKNOWN
Last Update Posted:
2009-03-26
First Post:
2009-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001585', 'term': 'Benzoyl Peroxide'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients whom inflammatory lesions were decreased %50 or more', 'timeFrame': 'two months'}], 'secondaryOutcomes': [{'measure': 'the number of patients whom were observed side effects', 'timeFrame': 'two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne', 'Nadifloxacin', 'benzoyl peroxide'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.', 'detailedDescription': 'Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of mild to moderate facial acne vulgaris\n* Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions\n\nExclusion Criteria:\n\n* Nodulocystic acne lesions more than 3 and pure comedonal acne\n* Additional truncal acne needs systemic therapy\n* Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months\n* Application of chemical peels and laser in last 4 weeks\n* Usage of hormones in last 3 months\n* Clinical signs of hyperandrogenism in females\n* Pregrancy and lactation\n* Hypersensitivity to interventions\n* Additional facial skin diseases (eg. atopic and seborreic dermatitis)\n* Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions'}, 'identificationModule': {'nctId': 'NCT00869492', 'briefTitle': 'Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'A Double Blind Randomised Comparison of Nadifloxacin 1% Cream Alone and Nadifloxacine %1 Cream With Benzoyl Peroxide 5% Solution in the Treatment of Mild to Moderate Facial Acne Vulgaris', 'orgStudyIdInfo': {'id': 'mar-der1'}, 'secondaryIdInfos': [{'id': 'dermatology1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly', 'interventionNames': ['Drug: nadifloxacine']}, {'type': 'OTHER', 'label': 'B', 'description': 'instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly', 'interventionNames': ['Drug: benzoyl peroxide', 'Drug: nadifloxacine']}], 'interventions': [{'name': 'benzoyl peroxide', 'type': 'DRUG', 'otherNames': ['Aknefug BP5 lotion'], 'description': 'benzoyl peroxide %5 solution once dailly', 'armGroupLabels': ['B']}, {'name': 'nadifloxacine', 'type': 'DRUG', 'otherNames': ['Nadixa 1% cream'], 'description': 'Nadifloxacine 1% cream twice dailly', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University school of medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Züleyha Yazıcı, doktor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Züleyha Yazıcı', 'oldOrganization': 'Dermatology Department of Marmara University School of Medicine'}}}}