Coagulation system alterations and venous thromboembolism risk associated with oral tranexamic acid treatment for facial melasma Melasma, Tranexamic Acid, Thrombelastography, Blood Coagulation, Venous Thrombosis
Conditions
Interventions
Participants will be allocated into two groups using computer generated block randomization. The randomization codes will be kept in sealed opaque envelopes and managed by a non clinical research assi
Experimental Drug,Placebo Comparator No treatment
Sponsors
Faculty of Medicine Siriraj Hospital
Eligibility
Sex/Gender
Female
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 30 and 55 years. 2. Diagnosed by a dermatologist with bilateral facial melasma of the epidermal, dermal, or mixed type. 3. Thai individuals of Asian descent. 4. Participants who voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women (assessed via menstrual history prior to enrollment; a pregnancy test will be performed if the menstrual history indicates potential pregnancy). 2. Participants with dermatitis, open wounds, or active skin infections on the face. 3. Participants with a history of using estrogen-containing hormones or contraceptives (injectable or oral) within 3 months prior to study enrollment. 4. Participants with a history of receiving topical or oral melasma treatments within 3 months prior to study enrollment. 5. Participants with a history of receiving facial laser treatment for melasma within 3 months prior to study enrollment. 6. Participants who do not consent to clinical photography for treatment evaluation. 7. Participants with a high risk of thromboembolism, meeting any of the following criteria: 7.1) History of arterial or venous thrombosis (e.g., coronary artery disease, cerebrovascular disease, peripheral vascular disease, deep vein thrombosis or venous thromboembolic disease, or pulmonary embolism). 7.2) History of treatment with anticoagulants or antiplatelet agents. 7.3) Diagnosed with thrombophilia. 7.4) Family history of thrombosis. 7.5) Diagnosed with diseases that increase the risk of thrombosis (e.g., malignancy, obesity, systemic lupus erythematosus, autoimmune diseases, nephrotic syndrome, cirrhosis, immune-mediated hematological disorders, atrial fibrillation, valvular heart disease, or active infections currently treated with antimicrobial agents). 7.6) History of trauma, major surgery, or inpatient hospitalization for at least 72 hours within 3 months prior to study enrollment. 7.7) History of central venous catheterization within 3 months prior to study enrollment. 7.8) Active smoker. 8. Participants with factors other than tranexamic acid that may affect coagulation and ROTEM interpretation, meeting any of the following criteria: 8.1) Currently receiving anticoagulants or antiplatelet agents. 8.2) History of bleeding diathesis, previous medical consultation for abnormal bleeding, or a history of receiving blood products or components due to abnormal bleeding. 8.3) Family history of bleeding disorders. 8.4) Abnormal liver function (AST or ALT levels greater than 2 times the upper limit of normal) or abnormal renal function (estimated glomerular filtration rate by CKD-EPI equation less than 60 mL per minute per 1.73 square meters). 8.5) Platelet count less than 100,000 per microliter, or prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) above the upper limit of the laboratory reference range. 9. Participants with other contraindications or precautions for tranexamic acid treatment, including: 9.1) History of hypersensitivity to tranexamic acid. 9.2) Abnormal renal function (estimated glomerular filtration rate by CKD-EPI equation less than 60 mL per minute per 1.73 square meters). 9.3) Subarachnoid hemorrhage or other active bleeding. 9.4) Active thromboembolic disease. 9.5) History of seizures. 9.6) Visual disturbances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostatic profiles assessed by rotational thromboelastometry At baseline, two months, and four months after enrollment Rotational thromboelastometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of venous thromboembolism (VTE) At weeks eight, sixteen, twenty, twenty eight, and forty after enrollment Clinical assessment and patient reporting of signs and symptoms of VTE, confirmed by imaging study if clinically suspected.,Clinical efficacy of melasma treatment At weeks eight, sixteen, twenty, twenty eight, and forty after enrollment Antera 3D melanin, Mexameter melanin and erythema indices, investigator mMASI score, photographic quartile grading by dermatologists, and patient subjective evaluation.,Incidence of adverse effects of tranexamic acid At weeks eight, sixteen, twenty, twenty eight, and forty after enrollment Clinical monitoring of patient reported symptoms, physical examinations, and routine laboratory blood tests including liver function tests recorded in the Case Record Form | — |
Countries
Thailand
Contacts
Public ContactBundarika Suwanawiboon
Faculty of Medicine Siriraj Hospital
Outcome results
None listed