Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04956367
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2021-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057896', 'term': 'Striae Distensae'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Used a computer-generated software to randomize the area to be treated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '16 weeks', 'description': 'Change in appearance based from clinical photos done in baseline, week 6, week 10, week 14 and week 16 . This will be assessed by quartile grading scale (poor, \\<25% improvement; fair, 25-50% improvement; good, 51-75% improvement; and excellent, \\>75% improvement)'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction rate', 'timeFrame': '16 weeks', 'description': 'Self-reported by the patient using a quartile grading system with the following grades: 0 as poor; 1 as fair; 2 as satisfied; or 3 as very satisfied. The rating will be done at weeks 6, 10, 14 and 16.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Striae Gravidarum', 'carbon dioxide laser', 'platelet-rich plasma'], 'conditions': ['Striae Gravidarum']}, 'referencesModule': {'references': [{'pmid': '26924405', 'type': 'RESULT', 'citation': 'Faghihi G, Keyvan S, Asilian A, Nouraei S, Behfar S, Nilforoushzadeh MA. Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial. Indian J Dermatol Venereol Leprol. 2016 Mar-Apr;82(2):162-8. doi: 10.4103/0378-6323.174378.'}]}, 'descriptionModule': {'briefSummary': 'This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum patients with ages 18 to 45 years\n* Fitzpatrick skin type III-V\n* having bilateral symmetrical SG of red, white or a combination of both types.\n\nExclusion Criteria:\n\n* pregnancy\n* breastfeeding\n* heavy consumption of alcoholic beverages\n* dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis\n* uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;\n* elevated liver function tests (SGPT, SGOT), and serum creatinine;\n* intake of any medications that may influence the outcome of the study;\n* intake of any vitamins/minerals or any supplements in the past 6 months; and\n* application of any topical agents (e.g., whitening, anti-aging) in the past 6 months'}, 'identificationModule': {'nctId': 'NCT04956367', 'briefTitle': 'Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jose R. Reyes Memorial Medical Center'}, 'officialTitle': 'Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2019-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CO2 laser with PRP', 'description': 'After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.', 'interventionNames': ['Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma', 'Device: CO2 laser with PRP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CO2 laser with placebo', 'description': 'After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.', 'interventionNames': ['Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma', 'Device: CO2 laser with placebo']}], 'interventions': [{'name': 'Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma', 'type': 'PROCEDURE', 'description': 'Carbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing.', 'armGroupLabels': ['CO2 laser with PRP', 'CO2 laser with placebo']}, {'name': 'CO2 laser with PRP', 'type': 'DEVICE', 'description': 'CO2 laser with PRP', 'armGroupLabels': ['CO2 laser with PRP']}, {'name': 'CO2 laser with placebo', 'type': 'DEVICE', 'description': 'CO2 laser with placebo', 'armGroupLabels': ['CO2 laser with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1014', 'city': 'Manila', 'state': 'NCR', 'country': 'Philippines', 'facility': 'Jose R Reyes Memorial Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Ivan Arni C Preclaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jose R. Reyes Memorial Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose R. Reyes Memorial Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser and placebo in the treatment of striae gravidarum: a randomized clinical trial', 'investigatorFullName': 'Ivan Arni Preclaro', 'investigatorAffiliation': 'Jose R. Reyes Memorial Medical Center'}}}}