Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma
Trial Parameters
Brief Summary
Melasma is a prevalent chronic facial pigmentation condition affecting Asian women of childbearing age, attributed to genetic predisposition, sunlight exposure, and hormonal changes. Treatment methods include phototherapy and medication, notably tranexamic acid, which inhibits melanin production. Ultra-pulsed shockwave therapy is a non-invasive approach that boosts skin cell vitality and collagen synthesis. Currently, there is a lack of comprehensive research on the effectiveness and safety of using ultra-pulsed shockwaves to deliver tranexamic acid for melasma treatment. This study will involve a non-randomized, self-half-face, pre-post controlled prospective clinical trial. This design aims to evaluate the depigmenting effects and safety profile of tranexamic acid delivered via ultra-pulsed shockwaves.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, any gender; 2. Diagnosis of melasma; 3. Able to comprehend and voluntarily sign a written informed consent form, and able to complete the treatment and follow-up as required. Exclusion Criteria: 1. History of other pigmentary disorders such as lentigines, Ota nevus, freckles, etc.; 2. History of oral retinoid or tetracycline-class photosensitizing drugs within the past 6 months prior to treatment; 3. History of facial injections, fillers, chemical peels, laser or radiofrequency treatments, or other treatments targeting pigmentation within the past 6 months prior to treatment; 4. Abnormal coagulation function; 5. History of oral glucocorticoids or immunosuppressive agents within the past 3 months prior to treatment; 6. Patients with malignant tumors; 7. Pregnant or lactating women; 8. Patients with active herpes simplex or herpes zoster on the face.