Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-29 @ 7:58 PM
Study NCT ID:
NCT00802958
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C064466', 'term': 'halobetasol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter', 'timeFrame': 'Over the course of a day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Halobetasol Propionate'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Community Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-tobacco using female subjects, 18 to 50 years of age\n* Demonstrated blanching response to Reference Drug\n* Weight within +/- 20% from normal for height and weight for body frame\n* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator\n* Signed and dated informed consent form which meets all criteria of current FDA regulations\n\nExclusion Criteria:\n\n* History of allergy to systemic or topical corticosteroids\n* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching\n* Presence of medical condition requiring regular treatment with prescription drugs\n* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing\n* Use of any tobacco products in the 30 days prior to study dosing\n* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing\n* Receipt of any drugs as part of a research study within 30 days prior to study dosing\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00802958', 'briefTitle': 'Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Padagis LLC'}, 'officialTitle': 'Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments', 'orgStudyIdInfo': {'id': '10216913'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort Group 1', 'description': 'Subjects number 1 to 30', 'interventionNames': ['Drug: Halobetasol Propionate 0.05% Ointment-Reference Product', 'Drug: Halobetasol Propionate 0.05% Ointment-Test Product']}, {'label': 'Cohort Group 2', 'description': 'Subjects number 31 to 56', 'interventionNames': ['Drug: Halobetasol Propionate 0.05% Ointment-Reference Product', 'Drug: Halobetasol Propionate 0.05% Ointment-Test Product']}, {'label': 'Cohort Group 3', 'description': 'Subject Numbers 57 to 76', 'interventionNames': ['Drug: Halobetasol Propionate 0.05% Ointment-Reference Product', 'Drug: Halobetasol Propionate 0.05% Ointment-Test Product']}], 'interventions': [{'name': 'Halobetasol Propionate 0.05% Ointment-Reference Product', 'type': 'DRUG', 'description': 'Small amount applied and evaluated over the course of a day', 'armGroupLabels': ['Cohort Group 1', 'Cohort Group 2', 'Cohort Group 3']}, {'name': 'Halobetasol Propionate 0.05% Ointment-Test Product', 'type': 'DRUG', 'description': 'Small amount applied and evaluated over the course of a day', 'armGroupLabels': ['Cohort Group 1', 'Cohort Group 2', 'Cohort Group 3']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Padagis LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}