Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 5:15 AM
Study NCT ID:
NCT05471934
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2022-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction Survey - Cicaplast Mains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006229', 'term': 'Hand Dermatoses'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'satisfaction rate', 'timeFrame': 'from baseline to Day28', 'description': 'satisfaction questionnaire with a 5-point scale'}], 'secondaryOutcomes': [{'measure': 'evaluation of hands problems (dryness, redness, irritations, cracks, fissures)', 'timeFrame': 'from baseline to Day28', 'description': 'evaluation on a 10-point scale (0 Not at all to 10 Very strong)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Eczema', 'Hand Dermatoses']}, 'descriptionModule': {'briefSummary': 'The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.', 'detailedDescription': 'The international, open, observational survey is conducted in 3 different countries.\n\nRegarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.\n\nOn patients who already used cream at the inclusion, the following analyses are performed:\n\n* Cross-tabulation between both visits,\n* Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,\n* Description of a summary variable in 3 classes (Improved / No change / Worsened).\n\nFor the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population corresponds to hairdressing professionals who are in permanent contact with irritating products (e.g. shampoos, hair colorants, oxidants, ...).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* professionals that work on different activities related to hair in a beauty salon\n* professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures\n\nExclusion Criteria:\n\n\\- professionals that do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05471934', 'briefTitle': 'Satisfaction Survey - Cicaplast Mains', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Satisfaction Survey - Cicaplast Mains', 'orgStudyIdInfo': {'id': 'LRP14011-CICAPLAST BAUME B5'}}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'Dermatology practices', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Dermatology practices', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Dermatology practices', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Delphine Kerob', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cosmetique Active International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}