Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-10 @ 3:11 PM
Study NCT ID:
NCT03272958
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2017-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010391', 'term': 'Pemphigoid, Bullous'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-09-03', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical characteristics of pruritus in patients with bullous pemphigoid', 'timeFrame': 'Day1 ( when diagnosis of bullous pemphigoid is made)', 'description': 'Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid'}], 'secondaryOutcomes': [{'measure': 'Impact of pruritus on quality of life in patients with bullous pemphigoid', 'timeFrame': 'Day 1 (when diagnosis of bullous pemphigoid is made )', 'description': 'Score 5D itch scale'}, {'measure': 'Impact of pruritus on quality of life in patients with bullous pemphigoid', 'timeFrame': 'Day1 (when diagnosis of bullous pemphigoid is made )', 'description': 'score ItchyQol (Itchy Quality of Life)'}, {'measure': 'Impact of pruritus on quality of life in patients with bullous pemphigoid', 'timeFrame': 'Day 1 (when diagnosis of bullous pemphigoid is made )', 'description': 'score ABQOL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pruritus', 'Bullous pemphigoid'], 'conditions': ['Bullous Pemphigoid']}, 'descriptionModule': {'briefSummary': 'Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.\n\nThe objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a new diagnosis of bullous pemphigoid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* pruriginous bullous pemphigoid lately diagnosed.\n* Without PB treatment\n* MMS (Mini Mental State Examination) ≥ 21\n* In hospitalization or consultation\n\nExclusion Criteria:\n\n* pregnant woman\n* nursing women'}, 'identificationModule': {'nctId': 'NCT03272958', 'acronym': 'PRURIPB', 'briefTitle': 'Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid', 'orgStudyIdInfo': {'id': '29BRC17.0066 ( PRURIPB)'}}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'CH Argenteuil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'AP-HP, Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33404', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'AP-HP, Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '76083', 'city': 'Le Havre', 'country': 'France', 'facility': 'CHU Le Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'HP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '79021', 'city': 'Niort', 'country': 'France', 'facility': 'CH de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'zip': '75006', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}