Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-01 @ 10:50 AM
Study NCT ID:
NCT06271135
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Quality of Life of Patients With Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elements influenced on quality of life of participants with rosacea', 'timeFrame': '17 months', 'description': 'The aim of the study was to assess whether antioxidant cosmetic procedures and selected lifestyle elements, especially dietary antioxidants have a significant impact on the quality of life of patients with rosacea.'}], 'secondaryOutcomes': [{'measure': 'Self-reported questionnaire', 'timeFrame': '17 months', 'description': "Author's questionnaire containing questions on sociodemographic status, anthropometic data, health behaviors, lifestyle, and information on rosacea."}, {'measure': 'Dietary Questionnaire', 'timeFrame': '17 months', 'description': 'Energy of diet and nutrients intake were assessed using 3-day 24-h dietary recalls (two randomly selected weekdays and one weekend day) and computer program Diet 6.0.'}, {'measure': 'The Physical Activity Questionnaire', 'timeFrame': '17 months', 'description': 'The physical activity was assessed by a short version of the International Physical Activity Questionnaire (IPAQ).'}, {'measure': 'DLQI (Dermatology Life Quality Index)', 'timeFrame': '17 months', 'description': 'The assessment of quality of life in rosacea was carried out using the Polish version of standardized questionnaire DLQI (Dermatology Life Quality Index).'}, {'measure': 'SWLS (Satisfaction With Life Scale)', 'timeFrame': '17 months', 'description': 'The assessment of satisfaction with life in patients with rosacea was carried out using the Polish version of standardized questionnaire SWLS (Satisfaction With Life Scale).'}, {'measure': 'BDI (Beck Depression Inventory)', 'timeFrame': '17 months', 'description': 'The assessment of depression in patients with rosacea was carried out using the Polish version of standardized questionnaire BDI (Beck Depression Inventory).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'cosmetics procedures', 'lifestyle', 'dietary antioxidants'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the inclusion criteria were: age ≥ 30 years,\n* diagnosis of rosacea according to the criteria of the National Rosacea Society Expert Committee (NRSEC) from 2019,\n* tolerance to the ingredients of the preparation used in the cosmetic intervention,\n* lack of pregnancy and lactation,\n* completion of a survey,\n* signed informed consent\n\nExclusion Criteria:\n\n* age \\< 30 years,\n* patients with other facial skin diseases (e.g. acne, psoriasis, eczema),\n* intolerance to the ingredients of the preparation used in the cosmetic treatment,\n* patients with neuropsychiatric diseases, pregnancy, lactation,\n* patients who did not sign informed consent to participate in the study\n* did not complete the survey questionnaire.'}, 'identificationModule': {'nctId': 'NCT06271135', 'briefTitle': 'Assessing the Quality of Life of Patients With Rosacea', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Bialystok'}, 'officialTitle': 'Assessing the Quality of Life of Patients With Rosacea', 'orgStudyIdInfo': {'id': 'LU20170508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with rosacea', 'interventionNames': ['Behavioral: CAPILLARY REPAIR SERUM 30ml']}], 'interventions': [{'name': 'CAPILLARY REPAIR SERUM 30ml', 'type': 'BEHAVIORAL', 'description': "Cosmetic procedures were performed on a group of patients after a cosmetic interview containing questions about contraindications to the procedure. The treatment was performed 3-times at 2-week intervals and consisted of cavitation peeling and sonophore-sis with an antioxidant preparation dedicated to vascular skin. The F-808 Skin Scrubber device was used for the treatment. After a month, the procedure was repeated. The stages of a cosmetologist's procedure during a cosmetic intervention were as follows: 1. make-up removal; 2. skin diagnostics, exclusion of contraindications, discussion of the procedure; 3. cavitation peeling - gentle skin cleansing using ultrasound; 4. applying an antioxidant cosmetic mixture (composition: rutin, horse chestnut and arnica extract, acerola, vitamin C, moisturizing complex of algae); 5. performing sonophoresis treatment; 6. applying the cream at the end; 7. discussion of indications for further care.", 'armGroupLabels': ['Participants with rosacea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15-089', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Medical University of Bialystok', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}], 'overallOfficials': [{'name': 'Małgorzata E Zujko, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Univeristy of Bialystok'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Bialystok', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lomza', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}