Riehl's Melanosis
Conditions
Interventions
combined treatment group:oral tranexamic acid, 250mg twice a day, with intense pulsed light therapy, every 4 weeks, a total of 6 times
monotherapy group:oral tranexamic acid, 250mg twice a day
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Riel's melanosis aged 18 to 65; 2. Fitzpatrick skin type III-IV; 3. Signed informed consent;
Exclusion criteria
Exclusion criteria: 1. Women that have oral contraceptives within 6 months, pregnant or lactating women; 2. Patients with severe cardiovascular diseases, severe liver and kidney dysfunction, elderly patients with severe diabetes history, psychiatric history, and infectious diseases; 3. Long-term outdoor work can not avoid the sun exposure; 4. Contact dermatitis, lupus erythematosus, eczema, and hormone-dependent dermatitis on the face; Patients with a medical history or family history of vitiligo or other pigmented diseases, or those easy to have scar; 5. Patients who had received topical therapy (2% hydroquinone cream, 0.025% tretinoin ointment, alpha hydroxy acid chemical exfoliation, topical or microinjection of tranexamic acid) or oral tranexamic acid tablets or other photoelectric therapy within 3 months before enrollment; 6. Patients with previous allergic history to aminocyclic acid preparations, patients with active intravascular coagulation, consumption coagulopathy and other contraindications to tranexamic acid; 7. Patients with thrombosis (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.) and those who may have thrombosis (including hereditary thrombophilia, such as antithrombin deficiency a, protein C deficiency, protein S deficiency, etc.); Or acquired thrombophilia, such as antiphospholipid syndrome, active malignant tumors, myeloproliferative neoplasms, paroxysmal nocturnal hemoglobinuria, Budd-Chiari syndrome, etc.); 8. Patients who cannot tolerate topical use of sunscreen; 9. Patients with a history of photoallergy (including sunlight allergy, ultraviolet allergy, laser treatment allergy, etc.); 10. Patients who have recently participated in other clinical trials, patients with high demands; 11. Patients who were judged by the trial investigator to be ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acquired dermal macular hyperpigmentation area and severity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| melanin index;erythema index;Global assessment by physicians;Patient satisfaction scale; | — |
Countries
China
Contacts
Public ContactZhongyi Xu
Huashan Hospital, Fudan University
Outcome results
None listed