Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04729556
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin erythema index', 'timeFrame': '17 days', 'description': 'Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.'}, {'measure': 'Skin melanin index', 'timeFrame': '17 days', 'description': 'Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.'}], 'secondaryOutcomes': [{'measure': 'Visual skin irritation', 'timeFrame': '17 days', 'description': 'Photographs of the contact skin area will be used for evaluating the presences and severity of skin irritation (rash, edema, papules, vesicles, and bullae) by dermatologists.'}, {'measure': 'Self-report topical side effects: rash, edema, vesicles, and itching', 'timeFrame': '17 days', 'description': 'Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Sore', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.', 'detailedDescription': 'A prospective, randomized, active-controlled clinical trial was conducted to initially evaluate safety of sericin-chitosan cream in comparison with a commercially available cream containing dimethicone for pressure sore treatment in healthy volunteers. The results of this study provided preliminary safety profile of sericin-chitosan cream before conducting the further clinical trial in specific population (pateints with early-stage pressure sore).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers at the age of 20 - 65 years\n* voluntarily sign inform consent\n\nExclusion Criteria:\n\n* Diagnosed with chronic skin conditions (e g. eczema and psoriasis) and immunocompromised diseases\n* Allergic to silk sericin and chitosan, and dimethicone\n* Received immunosuppressive therapy, antihistamine, and corticosteroid drugs two weeks before study enrollment.'}, 'identificationModule': {'nctId': 'NCT04729556', 'briefTitle': 'Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EC 19310-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sericin and chitosan cream', 'description': 'A flim-forming cream containing sericin and chitosan cream. Apply sericin and chitosan cream on the back area of healthy volunteers and cover with self-adhesive nonwoven fabric in induction phase I (72 hours), induction phase II (72 hours), and challenge phase (72 hours).', 'interventionNames': ['Device: Sericin and chitosan cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cavilon', 'description': 'Active control is a commercial cream containing dimethicone as the substance forms a durable, thin, and transparent film. The cream is used as a moisturizer to prevent the skin against irritation, dryness, and pressure ulcers.\n\nApply sericin and chitosan cream on the back area of healthy volunteers and cover with self-adhesive nonwoven fabric in induction phase I (72 hours), induction phase II (72 hours), and challenge phase (72 hours).', 'interventionNames': ['Device: Sericin and chitosan cream']}], 'interventions': [{'name': 'Sericin and chitosan cream', 'type': 'DEVICE', 'description': 'A novel film-forming cream containing sericin and chitosan', 'armGroupLabels': ['Cavilon', 'Sericin and chitosan cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10310', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}