Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT04580758
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel', 'timeFrame': 'one year', 'description': 'Effectiveness of each combination will be measured with OCT, depth of a fixed scar on each side of the face will be measured at baseline and then compared with 1 month after the last session and 3 months after the last session'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophic Acne Scar']}, 'descriptionModule': {'briefSummary': 'This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars', 'detailedDescription': 'The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.\n\nChoosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18\n* Both genders\n* Skin types III - V\n* Willingness and ability to comply with the requirements of the protocol\n* Atrophic acne scars\n\nExclusion Criteria:\n\n* Patients with active acne\n* Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.\n* Oral isotretinoin use in the previous 6 months\n* Pregnancy\n* Tendency to keloid formation\n* Patients with severe systemic illness or malignancy\n* Patients with connective tissue diseases\n* Patients with bleeding tendencies or any other hematological disease'}, 'identificationModule': {'nctId': 'NCT04580758', 'acronym': 'PRP', 'briefTitle': 'Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Kasr El Aini Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional laser with PRP fluid', 'description': 'Fractional CO2 laser then the PRP is injected afterwards', 'interventionNames': ['Combination Product: Fractional laser with PRP fluid or PRP gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional laser with PRP gel', 'description': 'Fractional CO2 laser then the PRP gel is injected afterwards', 'interventionNames': ['Combination Product: Fractional laser with PRP fluid or PRP gel']}], 'interventions': [{'name': 'Fractional laser with PRP fluid or PRP gel', 'type': 'COMBINATION_PRODUCT', 'description': '20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel', 'armGroupLabels': ['Fractional laser with PRP fluid', 'Fractional laser with PRP gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Yasmin A El Hadidy, MB BCh', 'role': 'CONTACT', 'email': 'yasmin_ahmed_92@yashoo.com', 'phone': '01142479792'}, {'name': 'Heba A Abd El Kader, MD', 'role': 'CONTACT'}], 'facility': 'Kasr Al Ainy Hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Heba A Abd El Kader, MD', 'role': 'CONTACT', 'email': 'H_abdelkader2007@yahoo.com', 'phone': '01142479792'}, {'name': 'Heba I Gawdat', 'role': 'CONTACT', 'email': 'H_abdelkader2007@yahoo.com', 'phone': '01142479792'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasmine Ahmed Abd El-Maguid El-Hadidy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dermatology Resident', 'investigatorFullName': 'Yasmine Ahmed Abd El-Maguid El-Hadidy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}