Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-04 @ 10:45 PM
Study NCT ID:
NCT03465150
Status:
RECRUITING
Last Update Posted:
2021-09-13
First Post:
2018-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
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': 'C000626399', 'term': 'Acne RA-1,2'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2033-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Acne stage', 'timeFrame': '2 years', 'description': 'composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne'}], 'secondaryOutcomes': [{'measure': "assessing patients' quality of life", 'timeFrame': '2 years', 'description': 'composite criteria. CADI score is calculated by summing the score of each question resulting in a possible maximum of 15 and a minimum of 0. The higher the score, the more the quality of life is impaired.'}, {'measure': 'cost of acne illness', 'timeFrame': '2 years', 'description': 'reimbursement data relating to hospitalizations and care in town recorded by the Health Insurance in the SNIIRAM database.'}, {'measure': 'Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample', 'timeFrame': '2 years', 'description': 'Correlation between bacterial and blood samples and the efficacity of the treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne', 'Cohort', 'prospective', 'risk factors'], 'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'With 24 million results associated with Google\'s searchon keywords "severe acne", Pr Dreno\'s team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients\' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.\n\nThis cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient\'s course of care and the associated costs. Pr Dreno\'s team will also build up a bio collection (bacteriological samples).', 'detailedDescription': 'All patients going for the first time in specialized consultation "acne" at Nantes University Hospital , and who meet the inclusion criteria will be included in the COPACNE cohort. Inclusion will take place at the first consultation, after information and agreement of the patient and, if applicable, his or her legal representatives. The frequency of each patient\'s follow-up visits will be determined on a case-by-case basis according to the patient\'s medical needs (generally, the interval between 2 visits is between 1 and 4 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients going for the first time in specialized consultation "acne"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with acne\n* Patient (or parents/guardians for minors) who are not opposed to participating in the cohort.\n* Subjects affiliated to an appropriate health insurance\n\nExclusion Criteria:\n\n* Dermatosis of the face other than acne\n* Refusal to participate by the minor or parent/guardian\n* Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)'}, 'identificationModule': {'nctId': 'NCT03465150', 'acronym': 'COPACNE', 'briefTitle': 'Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.', 'orgStudyIdInfo': {'id': 'RC17_0218'}}, 'armsInterventionsModule': {'interventions': [{'name': 'acne', 'type': 'OTHER', 'otherNames': ['acne vulgaris'], 'description': 'Patient with acne'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte Dreno, PU-PH', 'role': 'CONTACT', 'email': 'brigitte.dreno@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Brigitte DRENO', 'role': 'CONTACT', 'email': 'brigitte.dreno@wanadoo.fr', 'phone': '0240083137'}, {'name': 'Amir khammari', 'role': 'CONTACT', 'email': 'amir.khammari@chu-nantes.fr'}], 'overallOfficials': [{'name': 'Brigitte DRENO, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}