Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 12:40 PM
Study NCT ID:
NCT03885895
Status:
UNKNOWN
Last Update Posted:
2019-03-22
First Post:
2019-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pigmentation and severity index by clinical evaluation', 'timeFrame': '6 months to 1 year', 'description': 'Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up'}, {'measure': 'Melanin Index change by spectrophotometer', 'timeFrame': '6 months to 1 year', 'description': 'Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up'}, {'measure': "Blinded observers' evaluation", 'timeFrame': '6 months to 1 year', 'description': 'Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up'}, {'measure': 'Patient satisfaction rate', 'timeFrame': '6 months to 1 year', 'description': 'Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Therapeutic Efficacy']}, 'descriptionModule': {'briefSummary': 'Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).', 'detailedDescription': 'One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.\n\nThe other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.\n\nThe sessions of TXA will be every 2 weeks for 2 months.\n\nPostoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.\n\nFollow up after treatment monthly for 2 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Age group \\> 18years old.\n\nExclusion Criteria:\n\n* Pregnant and lactating females.\n* Keloid and scarring tendancy\n* Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.\n* Oral Isotretinoin 6 months prior to the study.\n* Active herpetic lesions.\n* Any concurrent active skin disease within the treated area.\n* Photosensitive skin conditions such as systemic lupus erythematous.\n* History of delayed wound healing.\n* Bleeding diathesis.\n* Medical conditions such as autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT03885895', 'briefTitle': 'Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)', 'orgStudyIdInfo': {'id': 'EgyFreckles'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with freckles (one side of the face)', 'description': 'one randomized side of the face will be treated by Intradermal Tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid Injectable Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with freckles (other side of the face)', 'description': 'other side will be treated by Q switched KTP laser', 'interventionNames': ['Device: Q switched KTP (532nm)']}], 'interventions': [{'name': 'Tranexamic Acid Injectable Product', 'type': 'DRUG', 'description': 'Ampoules used for intradermal injection', 'armGroupLabels': ['Participants with freckles (one side of the face)']}, {'name': 'Q switched KTP (532nm)', 'type': 'DEVICE', 'description': 'LASER', 'armGroupLabels': ['Participants with freckles (other side of the face)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11956', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Samar Tuqan', 'role': 'CONTACT', 'email': 'samartuqan@gmail.com', 'phone': '01003133495', 'phoneExt': '02'}], 'facility': 'Kasr El Ainy university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Samar Tuqan', 'role': 'CONTACT', 'email': 'samartuqan@gmail.com', 'phone': '01003133495', 'phoneExt': '02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Rana F Hilal, MD', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}