Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-30 @ 3:33 AM
Study NCT ID:
NCT04246957
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Comparison in Patients With Different Types of Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life', 'timeFrame': 'at day 0', 'description': "The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life)."}], 'secondaryOutcomes': [{'measure': 'Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life', 'timeFrame': 'at day 0', 'description': "The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alopecia', 'quality of life', 'partner'], 'conditions': ['Alopecia', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Every patient consulting in the dermatology department of Amiens' University Hospital for a primary alopecia will have to fill out 2 questionnaires of quality of life: one general (DLQI : Dermatology Life Quality Index) and one specific (Hair Specific Skindex 29). Every patient partner will have to complete one questionnaire of quality of life: FDLQI (Family DLQI).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients affiliated to social security\n* patients able to understand and fill out a questionnaire\n* patients over 18 years old\n* patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia\n\nExclusion Criteria:\n\n* minors\n* patients under guardianship, deprived of liberty\n* scalp affections other than alopecia\n* secondary alopecia'}, 'identificationModule': {'nctId': 'NCT04246957', 'acronym': 'RDACCQV', 'briefTitle': 'Quality of Life Comparison in Patients With Different Types of Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Quality of Life Comparison in Patients With Different Types of Alopecia', 'orgStudyIdInfo': {'id': 'PI2019_843_0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'general quality of life questionary', 'type': 'BEHAVIORAL', 'description': 'Every patient will have to fill out a general quality of life questionary : DLQI (Dermatology Life Quality Index)'}, {'name': 'specific quality of life questionary', 'type': 'BEHAVIORAL', 'description': 'Every patient will have to fill out a specific quality of life questionary : Hair Specific Skindex 29.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Catherine LOK, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Thomas Baltazard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Nesrine Zitouni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Fanny Dessirier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}