Melasma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years; 2. Gender: both male and female; 3. Patients with clinical or pathological diagnosis of melasma; 4. Fitzpatrick skin type III-V patients; 5. 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. Female subjects who are pregnant or lactating; 2. Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 1 year; 3. Laser treatment, oral tranexamic acid tablets and chemical exfoliation were performed six months before the study. Hydroquinone cream, corticosteroids and vitamin A analogues were used locally within three months of study enrollment; 4. There are other skin diseases on the face that may affect the efficacy evaluation, such as vitiligo, post-inflammation hyperpigmentation, rosacea; 5. Malignant tumors or precancerous lesions of the skin; 6. A history of photosensitivity or use of photosensitive drugs, such as sulfonamides and tetracyclines; 7. Severe exposure to sunlight more than two hours of outdoor work per day; 8. A personal or family history of deep vein thrombosis or thromboembolic events; 9. Treatment with anticoagulants; 10. Cicatrix and keloid tendency; 11. Active skin infections, active herpes simplex virus; 12. Patients with serious cardiovascular diseases, cerebrovascular diseases, liver and kidney dysfunction; 13. 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);Reflection confocal microscope image;Dermoscopy image;physician's global assessment, PGA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction survey;Security Assessment; | — |
Countries
China
Contacts
Hospital for Skin Disease (Institute of Dermatology), Chinese Academy of Medical Science