Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT07034560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in modified Melasma Area and Severity Index (mMASI)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in modified Melasma Area and Severity Index (mMASI) score from baseline to Week 12.\n\nThe mMASI ranges from 0 to 14.4, with higher scores indicating more severe melasma.'}, {'measure': 'Change in modified Melasma Area and Severity Index (mMASI) (Recurrence)', 'timeFrame': 'Week 12, Week 16, Week 20, Week 24', 'description': 'Recurrence is defined as an increase in mMASI score ≥50% from Week 12 to Week 24.\n\nThe mMASI ranges from 0 to 14.4; higher scores indicate worse melasma.'}], 'secondaryOutcomes': [{'measure': 'Melanin and Erythema Index', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24', 'description': 'Change in Melanin Index and Erythema Index at baseline to 24 weeks, measured by Mexameter.\n\nHigher values indicate increased pigmentation and erythema, respectively'}, {'measure': 'Change in skin texture, pore size, fine line (Antera 3D imaging)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24', 'description': 'Quantitative skin analysis using Antera 3D® imaging at baseline to 24 weeks. Lower scores indicate smoother texture, smaller pores, and fewer fine lines.'}, {'measure': 'Dermatology Life Quality Index (DLQI) score', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change in Dermatology Life Quality Index (DLQI) from baseline to 24 weeks. DLQI ranges from 0 to 30. Higher scores indicate greater impairment in quality of life.'}, {'measure': 'Patient satisfaction (Visual Analog Scale)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24', 'description': 'Patient satisfaction score at every 4 weeks using Visual Analog Scale (VAS) from 0 to 10.\n\nHigher scores indicate greater satisfaction.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': 'Number and severity of treatment-emergent adverse events during the 12-week intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melasma', 'Hyperpigmentation', 'Tranexamic Acid', 'Melatonin', 'mMASI', 'Recurrence', 'Randomized Controlled Trial', 'Skin Pigmentation'], 'conditions': ['Melasma', 'Treatment Outcome', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches.\n\nParticipants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream.\n\nAfter 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma.\n\nThe study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction.\n\nThis clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.', 'detailedDescription': 'Melasma is a chronic skin disorder characterized by symmetrical, hyperpigmented patches on sun-exposed areas, especially the face. Although its exact cause is not fully understood, hormonal influences, ultraviolet (UV) exposure, and genetic predisposition are contributing factors.\n\nTranexamic acid (TXA), an antifibrinolytic agent, has shown promising results in treating melasma by inhibiting melanogenesis through the plasminogen-plasmin pathway. Melatonin (MLT), a hormone with antioxidant and anti-inflammatory properties, has also demonstrated potential benefits in melasma management by reducing oxidative stress and interfering with the melanin synthesis pathway.\n\nThis prospective, randomized, controlled, evaluator-blinded clinical trial aims to compare the efficacy and recurrence outcomes of oral TXA (500 mg), oral MLT (2 mg), and placebo, each administered once daily for 12 weeks. After discontinuing the oral treatment, all participants will continue using sunscreen and base cream for an additional 12 weeks to evaluate recurrence.\n\nOutcome measures include modified Melasma Area and Severity Index (mMASI), Mexameter-based pigmentation indices, quality of life scores (DLQI), and patient satisfaction (VAS). The study is conducted at Benchakitti Park Hospital and includes 75 adult participants with epidermal or mixed-type melasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with the age above 18 years and above\n2. Patients diagnosed with epidermal or mixed-type melasma\n\nExclusion Criteria:\n\n1. Use of topical medications such as hydroquinone, whitening agents (e.g., arbutin, kojic acid, vitamin C, retinoids, and steroids) on melasma areas within 4 weeks prior to joining the study\n2. Chemical peeling within 4 weeks prior to joining the study\n3. Use of oral tranexamic acid or any supplements within 3 months prior to joining the study\n4. History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study\n5. History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study\n6. Pregnancy or breastfeeding\n7. Use of hormonal contraceptives within 1 year prior to joining the study\n8. Personal or family history of thrombotic disorders, such as deep vein thrombosis, pulmonary embolism, stroke, protein C or S deficiency, or antithrombin III deficiency\n9. History of more than 2 spontaneous abortion\n10. History of impaired kidney function\n11. History of cancer\n12. Smoking\n13. Heart disease (e.g., end-stage heart failure, chronic obstructive pulmonary disease, or use of prosthetic heart valves)\n14. History of allergy to oral tranexamic acid or melatonin\n15. Patients who are unable to follow up as per the study protocol\n16. Patients with Hori's nevus"}, 'identificationModule': {'nctId': 'NCT07034560', 'acronym': 'TXA-MELA', 'briefTitle': 'Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'CICM-MELASMA-MELATONIN-2025'}, 'secondaryIdInfos': [{'id': 'MTU-EC-OO-0-238/67', 'type': 'OTHER', 'domain': 'Human Research Ethics Committee, Faculty of Medicine, Thammasat University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic Acid (TXA)', 'description': 'Participants will receive 500 mg of oral tranexamic acid (Transamin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'EXPERIMENTAL', 'label': 'melatonin (Circadin)', 'description': 'Participants will receive 2 mg of oral melatonin (Circadin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.', 'interventionNames': ['Drug: melatonin (Circadin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a placebo capsule once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'description': '500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks.', 'armGroupLabels': ['Tranexamic Acid (TXA)']}, {'name': 'melatonin (Circadin)', 'type': 'DRUG', 'description': '2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks.', 'armGroupLabels': ['melatonin (Circadin)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule identical in appearance, taken once daily at bedtime for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Benchakitti Park Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Assoc. Prof. Premjit Juntongjin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulabhorn International College of Medicine, Thammasat University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to confidentiality concerns and lack of a formal data-sharing infrastructure. Data will be available upon reasonable request in de-identified, summary form only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Principal Investigator', 'investigatorFullName': 'Premjit Juntongjin, MD', 'investigatorAffiliation': 'Thammasat University'}}}}