Melasma patients aged 30-55 years Melasma, tranexamic acid, transcriptome, proteomic changes, tape strips
Conditions
Interventions
Participants will receive oral tranexamic acid at a dose of 250 mg per tablet, taken twice daily after meals, within 5-10 minutes, continuously for 4 months.,Participants will receive placebo tablets
Experimental Drug,Placebo Comparator Other,No Intervention Other
Oral tranexamic acid ,Placebo,Healthy controls
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Department of Dermatology, Mount Sinai Hospital, New York, USA ,Ouiheng International Healthcare Co., Ltd.,Skinova Co., Ltd.
Eligibility
Sex/Gender
Female
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Female participants aged between 30 and 55 years. 2. Diagnosed by a dermatologist with epidermal, dermal, or mixed-type melasma on both sides of the face. 3. Of Thai and Asian descent. 4. Voluntarily agrees to participate in the study by providing informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. Menstrual history will be taken prior to enrollment; if pregnancy is suspected, a pregnancy test will be considered. 2. Participants with facial skin conditions such as dermatitis, wounds, or infections. 3. Participants with a history of using estrogen-containing hormones or contraceptives (oral or injectable) within 3 months prior to study enrollment. 4. Participants with a history of using topical or oral treatments for melasma within 3 months prior to study enrollment. 5. Participants who have undergone laser treatment for melasma on the face within the past 3 months. 6. Participants who do not consent to facial photography for treatment evaluation. 7. Participants at high risk for thromboembolic events, defined as meeting any of the following criteria: 7.1 Previously diagnosed with arterial or venous thrombosis, such as coronary artery disease, cerebrovascular disease, peripheral vascular disease, deep vein thrombosis/venous thromboembolic disease, pulmonary embolism, etc. 7.2 History of receiving anticoagulant or antiplatelet therapy. 7.3 Diagnosed with thrombophilia (abnormally increased blood clotting tendency). 7.4 Family history of thromboembolic events. 7.5 Diagnosed with conditions that increase thromboembolic risk, such as cancer, obesity, lupus, autoimmune diseases, nephrotic syndrome, hematologic disorders with immune mechanisms, atrial fibrillation, valvular heart disease, or current serious infections under antimicrobial treatment. 7.6 History of major trauma, surgery, or hospitalization for more than 72 hours within the past 3 months. 7.7 Recent central venous catheter placement within the past 3 months. 8. Participants with factors-other than tranexamic acid-that may affect blood clotting, as follows: 8.1 Currently taking anticoagulants or antiplatelet medications. 8.2 Personal history of abnormal bleeding or requiring medical attention or blood products due to bleeding. 8.3 Family history of bleeding disorders. 8.4 Moderate to severe liver dysfunction (Child-Pugh class B or C), or impaired kidney function. 8.5 Thrombocytopenia, or prolonged prothrombin time and/or activated partial thromboplastin time above the laboratory reference range. 9. Participants with contraindications or precautions for tranexamic acid treatment, including: 9.1 Known allergy to tranexamic acid. 9.2 Impaired renal function. 9.3 Subarachnoid hemorrhage or other abnormal bleeding sites. 9.4 Active thromboembolic disease. 9.5 History of seizures. 9.6 Visual disturbances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global transcriptome Baseline, 4 months Analyze tape strips from lesional and nonlesional skin | — |
Secondary
| Measure | Time frame |
|---|---|
| Transcriptomic signature of tape strips Baseline, 4 months RNA sequencing,Proteomic changes Baseline, 4 months Olink Proseek assay,Correlation between tape strip biomarkers and clinical severity of melasma Baseline, 4 months, 1 & 3 & 6 months after treatment mMASI, RNA sequencing,Efficacy Baseline, 2 & 4 months, 1 & 3 & 6 months after treatment mMASI | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed