Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05483205
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normaderm Phytosolution Global Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565791', 'term': 'Acne, Adult'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2827}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.', 'timeFrame': '90-day use', 'description': 'Change in global acne severity\n\nusing a scale from 0=none to 5 very severe (GEA scale)'}], 'secondaryOutcomes': [{'measure': 'Change in seborrhea level', 'timeFrame': '90-day use', 'description': 'assessed on a visual analog scale from 0 (absent) to 10 (severe'}, {'measure': 'Change in skin hydration', 'timeFrame': '90-day use', 'description': 'assessed on a visual analog scale from 0=no hydration to 10=perfectly hydrated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne', 'observational study', 'dermocosmetic'], 'conditions': ['Acne, Adult']}, 'descriptionModule': {'briefSummary': 'The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.', 'detailedDescription': 'Acne is a chronic inflammatory condition, impacted by exposome factors. A dermocosmetic, Normaderm Phytosolution (NP), was developed to target hyperkeratosis, inflammation, and sebum, while protecting the skin barrier, and to be used either alone or in addition to acne medications. NP is a dermocosmetic specifically developed for acne-prone skin. The lightweight cream is easily absorbed and targets acne pathogenesis thanks to salicylic acid 2% for skin exfoliation, phyco-saccharide 2% for sebum reduction, and vitamin CG as anti-inflammatory ingredient, as well as ingredients that enable regeneration of the disrupted skin barrier, such as Vichy mineralizing water 60%, Bifida ferment lysate 1%, and hyaluronic acid 0.2%.\n\nThe study was conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).\n\nQualitative variables were described as numbers and percentages. 95% confidence intervals (CI) were calculated, where required. Quantitative variables were described as number, mean, standard deviation, median, minimum, maximum and number of missing data.\n\nAll statistical analyses were performed at a 5% significance using 2-sided tests, except normality, tested at the threshold of 1% (Shapiro-Wilk test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study took place at 337 sites in 11 countries worlwide. The study population consisted of 2827 patients. Overall, 75.3% were females; mean age was 26.7±8.0 years; 48% of subjects were aged between 18 and 25 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult men or women (age \\>18 years old) with mild to moderate acne (GEA scale 1-3).\n\nExclusion Criteria:\n\nPatients taking isotretinoin. Patients presenting with highly inflammatory acne, grade 4 or 5 on the GEA scale. Patients presenting with nodules.'}, 'identificationModule': {'nctId': 'NCT05483205', 'briefTitle': 'Normaderm Phytosolution Global Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Benefit of a Dermocosmetic in Mild to Moderate Adult Acne', 'orgStudyIdInfo': {'id': 'NP06072021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Normaderm Phytosolution Double-Correction Daily Care Moisturizer', 'type': 'DRUG', 'otherNames': ['NP'], 'description': "Normaderm Phytosolution (NP) was to be applied for up to 90 days once or twice daily, according to the investigator's prescription."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caba', 'country': 'Argentina', 'facility': 'Buenos Aires'}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'EuroDerma Clinic', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'DermaMedEst', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitatsklinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Eiffel Esthetics', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Polanco', 'country': 'Mexico', 'facility': 'Dermaarte Polanco', 'geoPoint': {'lat': 19.43332, 'lon': -99.19919}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Polimed', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'DClinic', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State Dermatological Clinic #10', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Amdv s.r.o. kozna amb', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Medical School', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Delphine Kerob, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cosmetique Active International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}