Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-18 @ 8:29 AM
Study NCT ID:
NCT02176551
Status:
WITHDRAWN
Last Update Posted:
2014-06-27
First Post:
2014-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business Reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Statistically significant superiority of the test Product 0405 to the vehicle', 'timeFrame': '28 days', 'description': 'Statistically significant superiority of the test Product 0405 to the vehicle'}], 'secondaryOutcomes': [{'measure': 'Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.', 'timeFrame': '28 days', 'description': 'Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.', 'detailedDescription': 'Treatment medication will be administered topically twice daily for 28 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Atopic Dermatitis\n* Good health with the exception of Atopic Dermatitis\n* Percent body surface area minimum requirements\n\nExclusion Criteria:\n\n* Subjects who are pregnant, nursing or planning a pregnancy'}, 'identificationModule': {'nctId': 'NCT02176551', 'briefTitle': 'Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fougera Pharmaceuticals Inc.'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects', 'orgStudyIdInfo': {'id': '0405-01-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Product 0405', 'description': 'Topical active investigational Product 0405', 'interventionNames': ['Drug: Product 0405']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Product 0405', 'description': 'Topical Placebo for Product 0405', 'interventionNames': ['Drug: Placebo for Product 0405']}], 'interventions': [{'name': 'Product 0405', 'type': 'DRUG', 'description': 'Product 0405 will be administered topically twice daily for 28 days.', 'armGroupLabels': ['Product 0405']}, {'name': 'Placebo for Product 0405', 'type': 'DRUG', 'description': 'Placebo for Product 0405 will be administered topically twice daily for 28 days.', 'armGroupLabels': ['Placebo for Product 0405']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Angela C Kaplan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fougera Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fougera Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}