Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-03 @ 9:42 AM
Study NCT ID:
NCT01644435
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-12', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Physician's assessment scores", 'timeFrame': 'End of Study - Month 3'}, {'measure': "Patient's assessment scores", 'timeFrame': 'End of Study - Month 3'}], 'primaryOutcomes': [{'measure': 'Changes in the Global Acne scarring classification', 'timeFrame': 'Day 0, End of study - Month 3'}], 'secondaryOutcomes': [{'measure': 'Photographic Assessment', 'timeFrame': 'Day 0, Month 1, Month 2 End of study - Month 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ACNE SCARRING']}, 'descriptionModule': {'briefSummary': 'This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.'}, '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* Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.\n* Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.\n* Subjects who are willing to give informed consent and adhere to the study protocol.\n\nExclusion Criteria:\n\n* Subjects with active infection or active acne.\n* Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.\n* Subjects with history of connective tissue disease.\n* Subjects with metabolic or hematopoietic disorders.\n* Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.\n* Subjects who have received prior chemotherapy and radiotherapy\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': 'NCT01644435', 'briefTitle': 'A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kasiak Research Pvt. Ltd.'}, 'officialTitle': 'A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring', 'orgStudyIdInfo': {'id': 'KRPL/HPL-AS/11-12/004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study arm A', 'description': 'Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring', 'interventionNames': ['Biological: Autologous Human Platelet Lysate']}, {'type': 'OTHER', 'label': 'Study arm B', 'description': 'Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.', 'interventionNames': ['Biological: Autologous Human Platelet Lysate']}], 'interventions': [{'name': 'Autologous Human Platelet Lysate', 'type': 'BIOLOGICAL', 'description': 'Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring', 'armGroupLabels': ['Study arm A']}, {'name': 'Autologous Human Platelet Lysate', 'type': 'BIOLOGICAL', 'description': 'Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring', 'armGroupLabels': ['Study arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400610', 'city': 'Thane', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kasiak Research Pvt Ltd', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}], 'overallOfficials': [{'name': 'Sharmila Patil, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermocosmetic laser center hair and skin clinic'}, {'name': 'Pankaj Maniar, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiance Cosmetology Clinique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasiak Research Pvt. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}