Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT00437151
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2007-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
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': 'D014831', 'term': 'Voice'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2007-02-16', 'studyFirstSubmitQcDate': '2007-02-17', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Percent adherence calculated from MEMS Caps readings', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': "Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire", 'timeFrame': '12 weeks'}, {'measure': 'Safety - tolerability and adverse event reporting', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.', 'detailedDescription': 'Same as above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris\n\nExclusion Criteria:\n\n* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)'}, 'identificationModule': {'nctId': 'NCT00437151', 'briefTitle': 'Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.', 'orgStudyIdInfo': {'id': 'US10022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'More frequent than normal office visits', 'interventionNames': ['Other: More frequent than normal office visits']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Electronic reminders (voice, e-mail, text messages)', 'interventionNames': ['Other: Electronic reminders (voice, e-mail, text messages)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Parental involvement / intervention reminders', 'interventionNames': ['Other: Parenteral involvement / intervention reminders']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'No intervention or reminders', 'interventionNames': ['Other: No intervention or reminders']}], 'interventions': [{'name': 'More frequent than normal office visits', 'type': 'OTHER', 'description': 'Mode of patient reminder', 'armGroupLabels': ['1']}, {'name': 'Electronic reminders (voice, e-mail, text messages)', 'type': 'OTHER', 'description': 'Mode of patient reminder', 'armGroupLabels': ['2']}, {'name': 'Parenteral involvement / intervention reminders', 'type': 'OTHER', 'description': 'Mode of patient reminder', 'armGroupLabels': ['3']}, {'name': 'No intervention or reminders', 'type': 'OTHER', 'description': 'Mode of patient reminder', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Ronald W Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma Laboratories, LP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ronald W. Gottschalk, MD / Medical Director', 'oldOrganization': 'Galderma Laboratories, L.P.'}}}}