Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT01078493
Status:
WITHDRAWN
Last Update Posted:
2016-09-26
First Post:
2010-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wrinkle Injection With Autologous Platelet Rich Plasma Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Protocol revision necessary.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2010-02-27', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Wrinkle Length', 'timeFrame': '3 months', 'description': 'All visible wrinkles are measured and the length is summed up to give the Total Wrinkle Length. Comparison of pre treatment and post treatment Total Wrinkle Length will be studied.'}], 'secondaryOutcomes': [{'measure': 'Side effect / Adverse Event', 'timeFrame': '3 months', 'description': 'Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelet rich plasma', 'PRP', 'wrinkles', 'MyCells®', 'CREATE', 'Life Source Medical Centre', 'Dr Tan Kok leong'], 'conditions': ['Wrinkles']}, 'descriptionModule': {'briefSummary': 'Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.', 'detailedDescription': '10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults more than 21 years of age\n* Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)\n\nExclusion Criteria:\n\n* Pregnant women.\n* Psychiatric patients.\n* Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia\n* Anticoagulants(eg.aspirin, warfarin)\n* Had other wrinkle therapy for less than a month.(laser, peels, injections)\n* Had facelift surgery for less than a year.\n* Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.\n* Involved in personal litigation against an aesthetic service provider'}, 'identificationModule': {'nctId': 'NCT01078493', 'acronym': 'WIPES', 'briefTitle': 'Wrinkle Injection With Autologous Platelet Rich Plasma Study', 'organization': {'class': 'NETWORK', 'fullName': 'Novena Medical Center'}, 'officialTitle': 'Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles', 'orgStudyIdInfo': {'id': 'CTC1000031'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MyCells® (injection of platelet rich plasma)', 'type': 'DEVICE', 'otherNames': ['MyCells autologous platelet preparation system'], 'description': 'PRP contains at least 1,000,000 platelets per mm3 or 2-6 times the native concentration of whole blood at a pH of 6.5 to 6.7'}]}, 'contactsLocationsModule': {'locations': [{'zip': '307506', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Life Source Medical Centre @ Novena Medical Center', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Kok Leong Tan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Life Source Medical Centre @ Novena Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novena Medical Center', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Dr Tan Kok Leong', 'oldOrganization': 'Life Source Medical Centre @ Novena Medical Center'}}}}