Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-30 @ 12:24 AM
Study NCT ID:
NCT01644461
Status:
UNKNOWN
Last Update Posted:
2012-07-25
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-24', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Photographic assessments', 'timeFrame': 'Day 0, Month 1, Month 2, End of study - Month 3'}, {'measure': "Physician's assessment scores", 'timeFrame': 'End of Study - 3 months'}, {'measure': "Patient's assessment scores", 'timeFrame': 'End of Study - 3 months'}], 'primaryOutcomes': [{'measure': 'Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile', 'timeFrame': 'Day 0, End of Study - 3 months'}], 'secondaryOutcomes': [{'measure': 'Global Aesthetic Improvement Scale', 'timeFrame': 'Day 0, End of study - Month 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Facial Wrinkles (Nasolabial Folds)']}, 'descriptionModule': {'briefSummary': "This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects (male and female), aged 18 to 40 years (both inclusive).\n* Subjects willing to refrain from any other treatment for Nasolabial Folds.\n* Subjects who are willing to give informed consent and adhere to the study protocol.\n\nExclusion Criteria:\n\n* Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc\n* Subjects with history of Connective tissue disease\n* Subjects with autoimmune diseases\n* Subjects unwilling to or unable to comply with the study protocol.\n* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days"}, 'identificationModule': {'nctId': 'NCT01644461', 'briefTitle': 'A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kasiak Research Pvt. Ltd.'}, 'officialTitle': 'A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)', 'orgStudyIdInfo': {'id': 'KRPL/HPL-FR/11-12/002B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Group', 'description': 'All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region', 'interventionNames': ['Other: Autologous Human Platelet Lysate']}], 'interventions': [{'name': 'Autologous Human Platelet Lysate', 'type': 'OTHER', 'description': 'All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400610', 'city': 'Thane', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kasiak Research Pvt Ltd', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}], 'overallOfficials': [{'name': 'Rachita Dhurat, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dr Rachita's Skin, Trichology & Aesthetic Centre"}, {'name': 'Geetanjali Shetty, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kapadia Multispeciality Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasiak Research Pvt. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}