Melasma
Conditions
Interventions
Experimental group:Drug: Tranexamic Acid
Control group:None
Sponsors
Hospital for Skin Disease (Institute of Dermatology), Chinese Academy of Medical Science
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female aged 18 - 60 years; 2. Patients with clinical or pathological diagnosis of melasma; 3. Fitzpatrick skin type III - V patients; 4. The subject or guardian can understand and provide written informed consent, and is able and willing to comply with all the time and requirements of interview, treatment and evaluation, including photo shooting that may be used for publishing and reporting.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation; 2. Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 1 year; 3. History of drugs containing tranexamic acid within 2 months of study enrollment; 4. History of drugs or photoelectric treatment within 4 weeks of study enrollment; 5. Patients with contraindications marked in the instructions of tranexamic acid tablets; 6. There are other skin diseases on the face that may affect the efficacy evaluation, such as vitiligo, post-inflammation hyperpigmentation, rosacea; 7. Patients with facial dermatitis, skin infections or systemic diseases that may affect facial conditions, such as systemic lupus erythematosus, chronic kidney disease or liver disease; 8. Female subjects with menorrhagia; 9. Severe exposure to sunlight (more than two hours of outdoor work per day); 10. History of substance abuse and/or alcohol and tobacco abuse within 1 year of study enrollment; 11. Personal or family history of thrombosis, such as cerebral thrombosis, myocardial infarction, thrombophlebitis, pulmonary embolism, etc.; 12. Have the tendency to form thrombosis or congenital abnormal coagulation; 13. Patients with abnormal history of D-dimer or fibrin degradation products or abnormal coagulation function test; 14. Patients with serious cardiovascular diseases, cerebrovascular diseases, liver and kidney dysfunction; 15. Other circumstances which make it unsuitable for the subject to participate in this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of mMASI (Modified Melasma Area and Severity Index);metabolomics testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| satisfaction investigation;change in dermatology life quality index;physician's global assessment, PGA; | — |
Countries
China
Contacts
Public ContactTong Lin
Hospital for Skin Disease (Institute of Dermatology), Chinese Academy of Medical Science
Outcome results
None listed