Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-02 @ 3:04 AM
Study NCT ID:
NCT05562661
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M89PF in Rosacea Associated With Erythema and Sensitive Skin
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-25', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'erythema', 'timeFrame': 'Day 0', 'description': 'assessment using a chromameter'}, {'measure': 'erythema', 'timeFrame': 'Day 15', 'description': 'assessment using a chromameter'}, {'measure': 'erythema', 'timeFrame': 'Day 30', 'description': 'assessment using a chromameter'}, {'measure': 'skin hydration', 'timeFrame': 'Day 0', 'description': 'using a corneometer'}, {'measure': 'skin hydration', 'timeFrame': 'Day 15', 'description': 'using a corneometer'}, {'measure': 'skin hydration', 'timeFrame': 'Day 30', 'description': 'using a corneometer'}, {'measure': 'transepidermal water loss', 'timeFrame': 'Day 0', 'description': 'tewameter'}, {'measure': 'transepidermal water loss', 'timeFrame': 'Day 15', 'description': 'tewameter'}, {'measure': 'transepidermal water loss', 'timeFrame': 'Day 30', 'description': 'tewameter'}], 'secondaryOutcomes': [{'measure': 'clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)', 'timeFrame': 'Day 0', 'description': 'VAS 0=none to 10=very severe'}, {'measure': 'clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)', 'timeFrame': 'Day 15', 'description': 'VAS 0=none to 10=very severe'}, {'measure': 'clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)', 'timeFrame': 'Day 30', 'description': 'VAS 0=none to 10=very severe'}, {'measure': 'skin sensitivity', 'timeFrame': 'Day 0', 'description': 'lactic acid skin stinging test'}, {'measure': 'skin sensitivity', 'timeFrame': 'Day 15', 'description': 'lactic acid skin stinging test'}, {'measure': 'skin sensitivity', 'timeFrame': 'Day 30', 'description': 'lactic acid skin stinging test'}, {'measure': 'Demodex density', 'timeFrame': 'Day 0', 'description': 'SSSB method'}, {'measure': 'Demodex density', 'timeFrame': 'Day 30', 'description': 'SSSB method'}, {'measure': 'local tolerability', 'timeFrame': 'Day 15', 'description': 'AE questioning'}, {'measure': 'local tolerability', 'timeFrame': 'Day 30', 'description': 'AE questioning'}, {'measure': 'subject satisfaction', 'timeFrame': 'Day 15', 'description': 'questionnaire on a scale from 0= very unsatisfied to 5 very satisfied'}, {'measure': 'subject satisfaction', 'timeFrame': 'Day 30', 'description': 'questionnaire on a scale from 0= very unsatisfied to 5 very satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rosacea', 'skin barrier', 'exposome', 'M89PF', 'splitface', 'sensitive skin'], 'conditions': ['Rosacea']}, 'referencesModule': {'references': [{'pmid': '36660190', 'type': 'DERIVED', 'citation': 'Berardesca E, Bonfigli A, Cartigliani C, Kerob D, Tan J. A Randomized, Controlled Clinical Trial of a Dermocosmetic Containing Vichy Volcanic Mineralizing Water and Probiotic Fractions in Subjects with Rosacea Associated with Erythema and Sensitive Skin and Wearing Protective Masks. Clin Cosmet Investig Dermatol. 2023 Jan 11;16:71-77. doi: 10.2147/CCID.S391893. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors.\n\nThis study assessed the benefit of M89PF in patients with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic with use of protective face masks.', 'detailedDescription': 'M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05562661', 'briefTitle': 'M89PF in Rosacea Associated With Erythema and Sensitive Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin', 'orgStudyIdInfo': {'id': 'M89PF splitface'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'M89PF/standard skin care', 'description': 'use of M89PF on one side of the face standard skin care products on the other side of the face'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'ISPE', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Delphine Kerob, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratoires Vichy, Levallois-Perret France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}