Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 4:03 AM
Study NCT ID:
NCT07056569
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance measured by reduction of disease severity and symptoms', 'timeFrame': 'End of treatment - 28 days.', 'description': "The evaluation and confirmation of the performance of 047\\_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 28 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value)."}], 'secondaryOutcomes': [{'measure': 'Performance measured by reduction of disease severity and symptoms at 14 days', 'timeFrame': '14 days of treatment', 'description': "The evaluation and confirmation of the performance of 047\\_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 14 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value)."}, {'measure': 'Eczema improvement assessed by Eczema Area and Severity Index (EASI) score', 'timeFrame': 'Treatment day 14 and treatment day 28', 'description': 'To evaluate the eczema improvement at 14 and 28 days of treatment with Eczema Area and Severity Index (EASI) score.'}, {'measure': 'Pruritus improvement assessed by VAS', 'timeFrame': 'Treatment day 14 and treatment day 28', 'description': 'Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.'}, {'measure': 'Anti-itch effect measured by patient reported assessment', 'timeFrame': 'Day 1 of treatment', 'description': 'Evaluated via subjective patient reported assessment the antiitch effect at day 1: immediate action (30sec-5min) and in 30 min.'}, {'measure': 'Long lasting itch relief measured by patient reported assessment', 'timeFrame': 'Treatment day 14 and 28', 'description': 'Evaluated via subjective patient/parent/caregiver reported assessment at day 14 and 28 - two times per day (8-10-12h)'}, {'measure': 'Performance measured by improvement in the Quality of Life', 'timeFrame': 'Treatment day 1, 14 and 28', 'description': 'Improvement in the quality of life of the subject related to their dermatitis will be assessed through the Dermatology Life Quality Index - Infant Dermatology Life Quality Index (DLQI/DLQC) questionnaire.'}, {'measure': 'Subject adherence to treatment', 'timeFrame': 'From enrollment to the end of study on day 28', 'description': "Subject's adherence to treatment will be evaluated from daily diary compilation and product accountability."}, {'measure': 'Product usability', 'timeFrame': 'From enrollment to the end of study on day 28', 'description': "Assess through the subject's overall acceptability of the treatment."}, {'measure': 'Overall performance of the device', 'timeFrame': 'From enrollment to the end of study on day 28', 'description': "Assessment of the subject's and investigator's global evaluation of the performance of the product by measuring their satisfaction."}, {'measure': 'MD Safety evaluation', 'timeFrame': 'From enrollment to the end of study on day 28', 'description': 'Evaluation of AE, SAE, ADE, SADE, ASADE, USADE incidence assessed by Investigator and reported according to the current legislation for the whole study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dermatitis', 'Atopic dermatitis', 'Contact dermatitis', 'Eczematous dermatitis'], 'conditions': ['Dermatitis, Contact', 'Dermatitis', 'Dermatitis, Chronic', 'Dermatitis, Eczematous', 'Dermatitis, Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.', 'detailedDescription': 'The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors.\n\nThe tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male/ female \\> 6 months \\< 65 years\n2. Patient diagnosed AD/CD\n3. Patient with EASI max \\<16\n4. Patient with IGA 1-3\n5. Patient in good condition with no serious systemic disease\n\nExclusion Criteria:\n\n1. Hypersensitivity to any 047\\_TD Dermatitis cream ingredients\n2. Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator\n3. Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study\n4. Any use of another topical emollient or other established treatment for AD/CD during the study at the site of flares (AD/CD lesions). Exception are usual hygienic products in the diaper area\n5. A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy\n6. Drug abuser\n7. Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old\n8. Could not provide written informed consent or parents' informed consent to have their child participate in the study"}, 'identificationModule': {'nctId': 'NCT07056569', 'briefTitle': 'Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biokosmes Srl'}, 'officialTitle': 'Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters', 'orgStudyIdInfo': {'id': '047 TD - BK2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '047_TD Dermatitis cream', 'description': '047\\_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.', 'interventionNames': ['Device: 047_TD Dermatitis cream twice a day for 28 days']}], 'interventions': [{'name': '047_TD Dermatitis cream twice a day for 28 days', 'type': 'DEVICE', 'description': '047\\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.', 'armGroupLabels': ['047_TD Dermatitis cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20154', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Pigatto, Professor', 'role': 'CONTACT', 'email': 'pigatto@pigattobersani.it', 'phone': '+39 348 704250'}, {'name': 'Paolo Pigatto, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Studio Medico Pigatto Bersani', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '37135', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giampiero Girolomoni, Professor', 'role': 'CONTACT', 'email': 'giampiero.girolomoni@univr.it', 'phone': '+39 045 8122547'}, {'name': 'Giampiero Girolomoni, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poliambulatorio Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '27058', 'city': 'Voghera', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michela Quaglini, Dr.', 'role': 'CONTACT', 'email': 'm_quaglini@libero.it', 'phone': '+39 335 563792'}, {'name': 'Michela Quaglini, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Studio Medico', 'geoPoint': {'lat': 44.99151, 'lon': 9.01175}}], 'centralContacts': [{'name': 'Donatella Mariani', 'role': 'CONTACT', 'email': 'ssu@solarishc.ch', 'phone': '+41 79 844 2600'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biokosmes Srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}