Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 8:19 AM
Study NCT ID:
NCT03429595
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2018-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007169', 'term': 'Impetigo'}], 'ancestors': [{'id': 'D013207', 'term': 'Staphylococcal Skin Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of Adverse Events and Laboratory Parameters', 'timeFrame': '14 days', 'description': 'incidences of adverse events reports and changes in significant laboratory parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impetigo']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '9 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of primary nonbullous or bullous impetigo\n* affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.\n* target area has total SIRS score of at least 3, including pus/exudate of at least 1\n* normally active and otherwise in good health by medical history and physical examination\n\nExclusion Criteria:\n\n* has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection\n* has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy\n* clinically significant mental illness\n* pregnant or breast-feeding\n* recent history, or strong potential for, alcohol or substance abuse.\n* skin condition that may interfere with the placement of study treatment or impede clinical evaluations\n* receipt of systemic drugs that affect the immune system within the past 3 months\n* receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours'}, 'identificationModule': {'nctId': 'NCT03429595', 'briefTitle': 'Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo', 'organization': {'class': 'INDUSTRY', 'fullName': 'UNION therapeutics'}, 'officialTitle': 'Randomized, Double-Blind, Vehicle Controlled, Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of Topical ATx201 GEL (2% and 4%) in Outpatients With Impetigo', 'orgStudyIdInfo': {'id': 'ATx201-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ATx201 GEL 2%', 'interventionNames': ['Drug: ATx201']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: ATx201 GEL 4%', 'interventionNames': ['Drug: ATx201']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: ATx201 GEL 4% plus vehicle', 'interventionNames': ['Drug: ATx201', 'Other: ATx201 GEL Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: ATx201 GEL 4% plus vehicle', 'interventionNames': ['Drug: ATx201', 'Other: ATx201 GEL Vehicle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 5: Vehicle', 'interventionNames': ['Other: ATx201 GEL Vehicle']}], 'interventions': [{'name': 'ATx201', 'type': 'DRUG', 'description': 'ATx201 GEL', 'armGroupLabels': ['Group 1: ATx201 GEL 2%', 'Group 2: ATx201 GEL 4%', 'Group 3: ATx201 GEL 4% plus vehicle', 'Group 4: ATx201 GEL 4% plus vehicle']}, {'name': 'ATx201 GEL Vehicle', 'type': 'OTHER', 'description': 'Vehicle', 'armGroupLabels': ['Group 3: ATx201 GEL 4% plus vehicle', 'Group 4: ATx201 GEL 4% plus vehicle', 'Group 5: Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'AntibioTx Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Boksburg', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -26.21197, 'lon': 28.25958}}, {'city': 'Claremont', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -33.98056, 'lon': 18.46528}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'eMkhomazi', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -30.20672, 'lon': 30.79641}}, {'city': 'Germiston', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -26.23481, 'lon': 28.17665}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site 2', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kraaifontein', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -33.84808, 'lon': 18.71723}}, {'city': 'Mpumalanga', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -29.81292, 'lon': 30.63646}}, {'city': 'Paarl', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site 2', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Soshanguve', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -25.47288, 'lon': 28.09919}}, {'city': 'Winnie Mandela', 'country': 'South Africa', 'facility': 'AntibioTx Investigative Site', 'geoPoint': {'lat': -28.70025, 'lon': 26.4581}}], 'overallOfficials': [{'name': 'Philippe Prokocimer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CMO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNION therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}