Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:48 AM
Study NCT ID:
NCT07360860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2025-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microneedling Alone vs Microneedling With PRP in the Treatment of Macular Amyloidosis; a Split Face Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Face split'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2025-12-27', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of macular amyloidosis using microneedling or PRP with microneedling', 'timeFrame': '3 months', 'description': "1. The clinical assessment will be performed based on the photographs taken at baseline, after 1month, and 3 months of the last session.\n2. Results will be measured by the Quartile grading scale:\n\n1\\< 25% improvement 2=25-\\<50% improvement 3=50-\\<75% improvement 4\\> 75% improvement 3. Degree of improvement in dermoscopic features will be measured by scoring system as follows : 0-25% = 0 (no improvement) 26-50% = 1(mild improvement) 51-75% = 2 (moderate improvement) 76- 100% = 3 (marked improvement) 4. Patients' satisfaction: Visual Analog Score for pain 5.measuring the Treatment Satisfaction Questionnaire for Medication (TSQM) for effectiveness.\n\n6\\. TPhysician global satisfaction will be assessed. 0-3 (unsatisfied) 4-6 (satisfied) 7-10 (highly satisfied)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Macular amyloidosis', 'Microneedling', 'PRP'], 'conditions': ['Macular Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This study is going to asses and compare the efficacy of treatment of macular amyloidosis using microneedling vs PRP with microneedling. Pruritus and pigmentation will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: • Both genders were included.\n\n* Patients above 18 years old.\n* Patients diagnosed by macular amyloidosis, proved by dermoscopy and histopathology.\n\nExclusion Criteria: • Prior use of topical therapies in the previous 4 weeks.\n\n* Prior use of any procedures such as chemical peel or laser treatment in the previous 1 month.\n* Prior use of any systemic treatment for macular amyloidosis in the past 12 weeks.\n* Patients with other skin conditions (e.g., psoriasis, eczema).\n* Immunocompromised patients (HIV, chemotherapy).\n* Patients with history of any type of autoimmune disorders, coagulopathies, and keloid tendency.\n* Known or suspected allergy to ingredients'}, 'identificationModule': {'nctId': 'NCT07360860', 'briefTitle': 'Microneedling Alone vs Microneedling With PRP in the Treatment of Macular Amyloidosis; a Split Face Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison Between Efficacy and Safety of PRP With Microneedling and Microneedling Alone in Treatment of Macular Amyloidosis; a Split Face Blinded Non Randomized Control Trial With Dermoscopic and Histopathologic Evaluation', 'orgStudyIdInfo': {'id': 'MS-59-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'microneedling', 'description': 'microneedling will be done on the first arm', 'interventionNames': ['Device: microneedling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'macular amyloidosis treated with microneedling and PRP', 'interventionNames': ['Device: microneedling with PRP']}], 'interventions': [{'name': 'microneedling', 'type': 'DEVICE', 'description': 'microneedling will be done for the one arm of macular amyloidosis', 'armGroupLabels': ['microneedling']}, {'name': 'microneedling with PRP', 'type': 'DEVICE', 'description': 'microneedling with PRP will be done on macular amyloidosis', 'armGroupLabels': ['macular amyloidosis treated with microneedling and PRP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira Elbendary, MD', 'role': 'CONTACT', 'email': 'aelbendary@kasralainy.edu.eg', 'phone': '+201552208664'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Cairo University', 'investigatorFullName': 'Amira Elbendary', 'investigatorAffiliation': 'Cairo University'}}}}