Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:01 AM
Study NCT ID:
NCT07472192
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With PDRN Versus Fractional CO₂ Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011089', 'term': 'Polydeoxyribonucleotides'}, {'id': 'D054020', 'term': 'Lasers, Gas'}], 'ancestors': [{'id': 'D011119', 'term': 'Polynucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vancouver Scar Scale', 'timeFrame': '4 months', 'description': 'The study used the standard Vancouver Scar Scale, which evaluates four characteristics of scars:\n\nTotal Score Range: 0 (normal skin) to 13 (severe hypertrophic scar)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Facial Scarring']}, 'referencesModule': {'references': [{'pmid': '29574803', 'type': 'BACKGROUND', 'citation': 'Kim JH, Jeong JJ, Lee YI, Lee WJ, Lee C, Chung WY, Nam KH, Lee JH. Preventive effect of polynucleotide on post-thyroidectomy scars: A randomized, double-blinded, controlled trial. Lasers Surg Med. 2018 Mar 25. doi: 10.1002/lsm.22812. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "Facial scars are frequently deemed unpleasant and can profoundly impact a patient's psychological health. This study compares the effectiveness, safety, and capacity to speed up scar healing in the maxillofacial region between fractional carbon dioxide (CO₂) laser therapy alone and polydeoxyribonucleotide (PDRN) combined with CO₂ laser therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age Limitations: Participants must be between 18 and 50 years of age.\n* Recently cut wounds or surgical scars from about (1-6 months).\n* Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding at the time of study.\n* Known allergy to PDRN.\n* Medication use that could affect wound healing or inflammation, such as:\n\n * Isotretinoin.\n * Anticancer drugs.\n * High-dose corticosteroids.\n * Anticoagulants.\n* Uncontrolled medical diseases (e.g., unstable diabetes, cardiac conditions).'}, 'identificationModule': {'nctId': 'NCT07472192', 'acronym': 'PDRN CO2 LASER', 'briefTitle': 'Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With PDRN Versus Fractional CO₂ Laser', 'organization': {'class': 'OTHER', 'fullName': 'Misr University for Science and Technology'}, 'officialTitle': 'Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With Polydeoxyribonucleotide (PDRN) Versus Fractional CO₂ Laser: A Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': '011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)', 'description': 'includes patients who will be enrolled for PDRN injection into the surgical scar', 'interventionNames': ['Drug: Polydeoxyribonucleotide', 'Device: Fractional CO2 laser assisted PDT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fractional CO₂ laser therapy with placebo saline injection', 'description': 'includes patients who will be enrolled for placebo saline injection into the surgical scar', 'interventionNames': ['Device: Fractional CO2 laser assisted PDT']}], 'interventions': [{'name': 'Polydeoxyribonucleotide', 'type': 'DRUG', 'description': 'intralesional PDRN injections', 'armGroupLabels': ['Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)']}, {'name': 'Fractional CO2 laser assisted PDT', 'type': 'DEVICE', 'otherNames': ['co2 laser'], 'description': 'Fractional carbon dioxide (CO₂) laser therapy for facial scars', 'armGroupLabels': ['Fractional CO₂ laser therapy with placebo saline injection', 'Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abeer Mohamed Kamal, Phd of OMFS', 'role': 'CONTACT', 'email': 'abeer.kamal@must.edu.eg', 'phone': '01005168009', 'phoneExt': '002'}, {'name': 'Omnia Tarek Hosni, Bachelor Degree', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Misr University for Science and Technology', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Omnia Tarek Hosni', 'role': 'CONTACT', 'email': '200048686@must.edu.eg', 'phone': '01117196173', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator in Oral & Maxillofacial Surgery Department, MUST', 'investigatorFullName': 'Omnia Tarek Hosni', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}