Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01220102
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2010-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne
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': 'D000068816', 'term': 'Adapalene'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D000068801', 'term': 'Adapalene, Benzoyl Peroxide Drug Combination'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of acne', 'timeFrame': 'at baseline and after 12 weeks of treatment', 'description': 'efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system'}], 'secondaryOutcomes': [{'measure': 'local skin irritations', 'timeFrame': 'over 12 weeks'}, {'measure': 'treatment adherence', 'timeFrame': 'at final examination after 12 weeks of treatment', 'description': 'treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne', 'Epiduo', 'adapalene/ benzoyl peroxide'], 'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.', 'detailedDescription': 'The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has been diagnosed with moderate inflammatory acne\n* Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study\n* The patient is aged between 12 and 20 years\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Hypersensitivity to the medication or any of the ingredients\n* Other contraindications mentioned in the Epiduo SPC'}, 'identificationModule': {'nctId': 'NCT01220102', 'acronym': 'TEENA', 'briefTitle': 'Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma Laboratorium GmbH'}, 'officialTitle': 'Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne', 'orgStudyIdInfo': {'id': 'TEENA'}}, 'armsInterventionsModule': {'interventions': [{'name': '0.1% adapalene/ 2.5% benzoyl peroxide', 'type': 'DRUG', 'otherNames': ['Epiduo'], 'description': 'topical application, once per day'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Harald PM Gollnick, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma Laboratorium GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}