Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT06467032
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing assessment by the Investigator (number of days for complete re-epithelialization)', 'timeFrame': 'from baseline to Day19', 'description': 'assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: \\<25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: \\>75% of the lesion area); 5 (Complete healing).'}], 'secondaryOutcomes': [{'measure': 'wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)', 'timeFrame': 'from baseline to Day19', 'description': 'assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: \\<25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: \\>75% of the lesion area); 5 (Complete healing).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['re-epithelialization', 'superficial CO2 laser resurfacing', 'Cicaplast Baume B5'], 'conditions': ['Wound Heal']}, 'descriptionModule': {'briefSummary': 'This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study.\n\nThe objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.', 'detailedDescription': 'This clinical trial is conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.\n\nStatistical method: analysis will be performed using R software version 4.0.2. or higher. All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk). All efficacy evaluation will be done on the Per Protocol Set.\n\nThe categorical variables are summarized by frequency and percentage for each response category (N, %). The continuous variables are summarized using means, medians, minimum, maximum, and standard deviations for the data collected at each visit.\n\nSample size determination: A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91% at a risk alpha of 0.05 and assuming a common standard deviation of ±2.7 days. Twenty-five (25) subjects will be included in the study to take into account possible dropouts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* phototype II and III on the Fitzpatrick scale\n* subjects with normal clinical examination and medical history compatible with the study\n\nExclusion Criteria:\n\n* subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology\n* subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study\n* subject who has taken systemic treatment for more than 5 days in the month prior to inclusion'}, 'identificationModule': {'nctId': 'NCT06467032', 'briefTitle': 'Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing', 'orgStudyIdInfo': {'id': 'LRP21007 Cicaplast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'superficial CO2 laser resurfacing', 'description': 'The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product.', 'interventionNames': ['Other: superficial CO2 laser resurfacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser untreated side', 'description': 'The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product.', 'interventionNames': ['Other: Laser untreated side']}], 'interventions': [{'name': 'superficial CO2 laser resurfacing', 'type': 'OTHER', 'description': 'Application of the tested product and comparators on the laser treated side of the back', 'armGroupLabels': ['superficial CO2 laser resurfacing']}, {'name': 'Laser untreated side', 'type': 'OTHER', 'description': 'Application of the tested product and comparators on the laser untreated (control) side of the back', 'armGroupLabels': ['Laser untreated side']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'facility': 'CPCAD', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Catherine Queille-Roussel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Pharmacologie Clinique Applique a la Dermatologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}