Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04697992
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2020-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'blinded investigators that assess grade of improvement at end of the study compared to baseline'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'clinical trial, patients were divided into two groups, 30 each.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2020-12-26', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation', 'timeFrame': '10 weeks (patients are assissed 1 month after the last session)', 'description': 'this is evaluated using dermoscopy (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=\\>75% improvement)'}, {'measure': 'evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation', 'timeFrame': '10 weeks (patients are assissed 1 month after the last session)', 'description': 'clinical improvement by two blinded investigators (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=\\>75% improvement)'}, {'measure': 'evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation', 'timeFrame': '10 weeks (patients are assissed 1 month after the last session)', 'description': 'clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)'}, {'measure': 'evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation', 'timeFrame': '10 weeks (patients are assissed 1 month after the last session)', 'description': 'dermatology life quality index (score from 0 to 30 the higher the worst)'}, {'measure': 'evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation', 'timeFrame': '10 weeks (patients are assissed 1 month after the last session)', 'description': 'patient visual analogue score (score from 0 to 10 the higher the worst)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periorbital hyperpigmentation', 'Vitamin C', 'Tranexamic acid', 'Microneedling'], 'conditions': ['Periorbital Hyperpigmentation']}, 'descriptionModule': {'briefSummary': "Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).", 'detailedDescription': 'Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders.\n* age ≥ 18 years.\n* pigmentary, vascular and mixed types of dark halos\n\nExclusion Criteria:\n\n* pregnancy and lactation\n* patients who received treatment in the past 3 months\n* patients with active dermatologic diseases or history of atopic dermatitis.\n* history of allergy to tranexamic acid or vitamin c\n* history of keloid or hypertrophic scars\n* pure structural type of dark halos, pigmentary demarcation lines'}, 'identificationModule': {'nctId': 'NCT04697992', 'briefTitle': 'Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study', 'orgStudyIdInfo': {'id': 'cosmo26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).', 'interventionNames': ['Drug: vitamin c 20%']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'one eye was treated with tranexamic acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).', 'interventionNames': ['Drug: Tranexamic acid 5mg/ml']}], 'interventions': [{'name': 'vitamin c 20%', 'type': 'DRUG', 'otherNames': ['vitamin c 20% global cosmetic solutions'], 'description': 'one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).', 'armGroupLabels': ['group A']}, {'name': 'Tranexamic acid 5mg/ml', 'type': 'DRUG', 'otherNames': ['kapron 500mg/ 5ml'], 'description': 'one eye was treated with tranexamin acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling)', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Doaa Mohsen', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'im looking forward sharing the data but i have no plan yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doaa Mohsen Fadl Morsy, Principal Investigator, teaching assistant at dermatology department', 'investigatorFullName': 'Doaa Mohsen', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}