Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT04995302
Status:
UNKNOWN
Last Update Posted:
2021-08-06
First Post:
2021-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study, one scar in one subject, will be divided into two areas, one-half of the scar will receive an intervention of microneedling, and the other half will receive microneedling+amnion bilayer. Hence, one subject will receive both interventions at the same time'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-31', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Subjective Pain in one month', 'timeFrame': 'Baseline, day 7, day 30', 'description': 'Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)'}, {'measure': 'Change in Erythema Degree in one month', 'timeFrame': 'Baseline, day 7, day 30', 'description': 'Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)'}, {'measure': 'Change in Dermoscopy Evaluation in one month', 'timeFrame': 'Baseline, day 7 , day 30', 'description': 'Qualitative description of blood vessel structure, pigmentation density and erythema'}, {'measure': 'Change in Biopsy Evaluation in one month', 'timeFrame': 'Baseline, Day 7 and day 30', 'description': 'Descriptive evaluation using HE staining'}, {'measure': 'Change in Skin Thickness in one month', 'timeFrame': 'Baseline, Day 7 and day 30', 'description': 'Evaluation with USG of epidermal and dermal layer (in pixels)'}, {'measure': 'Change in Subjective Improvement in one month', 'timeFrame': 'Baseline , Day 7 and day 30', 'description': 'Using Patient and Observer Scar Assessment Scale (Patients scored from 1-10 in pain, itch, color, stiffness, thickness and irregularity of their scar, observer gives score on vascularity, pigmentation, thickness, relief, pliability, and surface area)'}, {'measure': 'Change in Subjective Improvement in one month', 'timeFrame': 'Baseline , Day 7 and day 30', 'description': 'Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microneedling', 'Amnion bilayer', 'Scar'], 'conditions': ['Scars, Hypertrophic', 'Burn Scar']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021.', 'detailedDescription': "High degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. For years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. This study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. This is an interventional study with 17 samples, aged 18-50 years old. Therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, aged 18-50 years old\n* Patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter.\n* Patients are willing to participate in the study and sign an informed consent form\n\nExclusion Criteria:\n\n* Patients with scars less than 5 cm in diameter\n* Patients with scars localized solely in the face\n* Hypertrophic scars with keloid\n* Patients with comorbidities'}, 'identificationModule': {'nctId': 'NCT04995302', 'briefTitle': 'Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue', 'orgStudyIdInfo': {'id': 'MicroneedlingScar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Microneedling and Amnion Bilayer', 'description': 'Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy.', 'interventionNames': ['Procedure: Microoneedling and Amnion Bilayer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Microneedling', 'description': 'Microneedling is a dermaroller procedure that uses small needles to prick the skin.', 'interventionNames': ['Procedure: Microoneedling']}], 'interventions': [{'name': 'Microoneedling and Amnion Bilayer', 'type': 'PROCEDURE', 'description': 'Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours.', 'armGroupLabels': ['Microneedling and Amnion Bilayer']}, {'name': 'Microoneedling', 'type': 'PROCEDURE', 'description': 'Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing.', 'armGroupLabels': ['Microneedling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Pusat', 'country': 'Indonesia', 'contacts': [{'name': 'Irma B Sitohang, MD, Ph.D', 'role': 'CONTACT', 'email': 'irma_bernadette@yahoo.com', 'phone': '+62818130761'}], 'facility': 'dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Irma B Sitohang', 'role': 'CONTACT', 'email': 'irma_bernadette@yahoo.com', 'phone': '+62818130761'}], 'overallOfficials': [{'name': 'Irma B Sitohang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr.dr.Irma Bernadette, SpKK (K)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Irma Bernadette S. Sitohang, MD, PhD - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia', 'investigatorFullName': 'Dr.dr.Irma Bernadette, SpKK (K)', 'investigatorAffiliation': 'Indonesia University'}}}}