Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 11:51 PM
Study NCT ID:
NCT05887232
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quartile grading scale for assessment of scars', 'timeFrame': '16 weeks', 'description': "Quartile grading scale was used to assess effectiveness of CO2 laser and CO2 laser with Platelet rich plasma in scars.Minimum score=0,Maximum Score=3 .Maximum score means better outcome.The Quartile grading scale (score 0 is \\<25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is \\>75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CO2 Laser in Scars']}, 'descriptionModule': {'briefSummary': "Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.\n\nStudy design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.\n\nMethodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is \\<25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is \\>75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value \\<0.05 as significant, was used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-50 years\n* Fitzpatrick skin type III-V\n* Presented with post-acne, post traumatic or post burn scars\n* all those patients emotionally balanced with realistic expectations were included in the study.\n\nExclusion Criteria:\n\n* scar that was less than 6 months old\n* if they had an active infection or inflammatory skin condition\n* having a history of malignancy\n* a known connective tissue illness\n* history of excessive bleeding or keloids\n* unrealistic expectations\n* pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05887232', 'briefTitle': 'Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Abbottabad'}, 'officialTitle': 'Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars', 'orgStudyIdInfo': {'id': 'CMHAbbottabad1988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional Co2 laser', 'description': "Patient in group A received FCL treatment's four sessions four weeks apart.", 'interventionNames': ['Procedure: Fractional CO2 laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet Rich Plasma', 'description': 'Group B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart.', 'interventionNames': ['Procedure: Fractional CO2 with Platelet Rich Plasma']}], 'interventions': [{'name': 'Fractional CO2 laser', 'type': 'PROCEDURE', 'description': 'Patient in group A received FCL treatments four sessions with four weeks apart', 'armGroupLabels': ['Fractional Co2 laser']}, {'name': 'Fractional CO2 with Platelet Rich Plasma', 'type': 'PROCEDURE', 'description': 'Group B received four PRP and FCL sessions 4 weeks apart', 'armGroupLabels': ['Platelet Rich Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22010', 'city': 'Abbottabad', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Dr.Zahra Nigar', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital Abbottabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Zahra Nigar', 'investigatorAffiliation': 'Combined Military Hospital Abbottabad'}}}}