Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04233320
Status:
UNKNOWN
Last Update Posted:
2020-01-21
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale', 'timeFrame': '3 months', 'description': 'The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Vancouver scar scale', 'timeFrame': '3 months', 'description': 'The range of score is 0 to 10. Higher scores mean a worse outcome.'}, {'measure': 'Melanin index', 'timeFrame': '3 months', 'description': 'Melanin index will be evaluated using cutometer.'}, {'measure': 'Erythema index', 'timeFrame': '3 months', 'description': 'Erythema index will be evaluated using cutometer.'}, {'measure': 'Adverse effect', 'timeFrame': '3 months', 'description': 'Adverse effect will be observed in term of erythema, edema, papules, vesicles, and bullae. The range of erythema score is 0 to 3. The range of edema score is 0 to 4. Higher scores mean a worse outcome. Papules, vesicles, and bullae will be recorded as apperance or clear.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scar', 'Allium Cepa', 'post-cesarean'], 'conditions': ['Cicatrix']}, 'descriptionModule': {'briefSummary': 'The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years\n* Have Post-Cesarean Surgical Scars at least 1 month\n* REEDA scale = 0 score\n* Able to read and write Thai\n* Able to follow the research plan\n* Able to meet all the researchers throughout the period of participation in the project\n\nExclusion Criteria:\n\n* Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study\n* There is radiation in the area of the post-cesarean surgical scars\n* Chronic skin diseases such as psoriasis, chronic dermatitis, allergies\n* Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study\n* Have a history of silicone allergy or onion extract'}, 'identificationModule': {'nctId': 'NCT04233320', 'briefTitle': 'Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment', 'orgStudyIdInfo': {'id': '547/62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'silicone cream containing Allium Cepa extract', 'description': 'Silicone cream containing Allium Cepa extract will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.', 'interventionNames': ['Device: silicone cream containing Allium Cepa extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'commercial scar gel', 'description': 'Commercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.', 'interventionNames': ['Device: Commercial scar gel']}], 'interventions': [{'name': 'silicone cream containing Allium Cepa extract', 'type': 'DEVICE', 'description': 'silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.', 'armGroupLabels': ['silicone cream containing Allium Cepa extract']}, {'name': 'Commercial scar gel', 'type': 'DEVICE', 'description': 'Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.', 'armGroupLabels': ['commercial scar gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pornanong Aramwit, Ph.D', 'role': 'CONTACT', 'email': 'aramwit@gmail.com', 'phone': '+66899217255'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}