Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-10 @ 1:43 AM
Study NCT ID:
NCT02385760
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2015-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
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': 'C000625351', 'term': 'acebilustat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as measured by inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.'}, {'measure': 'Safety as measured by the incidence of treatment emergent adverse events', 'timeFrame': '12 weeks', 'description': 'Incidence of treatment emergent adverse events as compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Efficacy as measured by Investigator Global Assessment (IGA)', 'timeFrame': '12 weeks', 'description': 'The proportion of participants achieving Grade 0 or 1 with a two grade improvement in the IGA from baseline to the end of the 12 weeks of treatment as compared to placebo.'}, {'measure': 'Efficacy as measured by non-inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Facial Acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must provide Informed consent.\n2. Male or female aged 16 to 44 inclusive.\n3. Moderate to severe facial acne vulgaris as defined in the protocol.\n\nExclusion Criteria:\n\n1. Positive testing for HIV, HBsAg, or hepatitis C virus (HCV).\n2. Females who are pregnant, lactating, or planning to become pregnant during the study.\n3. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study.\n4. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis).\n5. Concurrent or previous use of an investigational drug or device within 30 days prior to screening.\n6. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne.\n7. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions.\n8. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.'}, 'identificationModule': {'nctId': 'NCT02385760', 'briefTitle': 'CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Celtaxsys, Inc.'}, 'officialTitle': 'A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CTX-4430-AV-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks', 'interventionNames': ['Drug: CTX-4430']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CTX-4430', 'type': 'DRUG', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2606', 'city': 'Phillip', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Clinical Trials Woden Dermatology', 'geoPoint': {'lat': -35.35035, 'lon': 149.09151}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Dermatology', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Central Sydney Dermatology', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Skin Centre', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '4000', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Siller Medical', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Research', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Skin and Cancer Foundation', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Dermatology', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Optimal Clinical Trials', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '3210', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Clinical Trials New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Lynda J Spelman, MB BS, FACD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veracity Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celtaxsys, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Network Services (CNS) Pty Ltd', 'class': 'INDUSTRY'}, {'name': 'Celtaxsys Aus Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}