Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-11 @ 5:02 PM
Study NCT ID:
NCT04624867
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2020-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Irritation Evaluation', 'timeFrame': '21 days', 'description': 'To evaluate skin irritation after exposure to HP-1050 compared to XULANE®'}, {'measure': 'Sensitization Evaluation', 'timeFrame': '48 hours', 'description': 'To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cumulative Irritation and Sensitization']}, 'descriptionModule': {'briefSummary': 'A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.', 'detailedDescription': 'This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;\n* Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;\n* Subjects who are willing to stop using any current contraceptives for the duration of the study;\n\nExclusion Criteria:\n\n* Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;\n* Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;\n* Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;'}, 'identificationModule': {'nctId': 'NCT04624867', 'briefTitle': 'Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noven Therapeutics'}, 'officialTitle': 'A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females', 'orgStudyIdInfo': {'id': 'HP-1050-US-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HP-1050 patch', 'description': 'HP-1050 and Xulane will be administered simultaneously.', 'interventionNames': ['Drug: HP-1050 Patch']}], 'interventions': [{'name': 'HP-1050 Patch', 'type': 'DRUG', 'description': 'Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.', 'armGroupLabels': ['HP-1050 patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT'}], 'facility': 'QPS Missouri', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'ClinicalTrials@noven.com', 'phone': '305 253 5099'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noven Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}