Port-Wine Stain
Conditions
Interventions
test group:HMME-PDT
control group:pulsed dye laser therapy
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. were clinically diagnosed with PWS; 2. Aged 2 to 65 years; 3. PWS was in the same anatomic plane and the lesion area was larger than 50 square centimeters; 4. PWS belongs to the red type or purple type; 5. Fitzpatrick skin type II - IV type; 6. has read the instructions and willing and able to be treated in accordance with the requirements of the program and revisit in time; 7. agree to sign informed consent. 8.8. The guardian was required to sign the informed consent when the patient was over 14 and under 18 years. The patient was also required to sign the informed consent for child 9. The guardian was required to sign the informed consent for vulnerable groups when the patient was over 8 and under 14 years. The patient was also required to sign the informed consent for child 10. The guardian was required to sign the informed consent for vulnerable groups when the patient was over 2 and under 8 years.
Exclusion criteria
Exclusion criteria: 1. with other skin diseases that might interfere with the evaluation of the effectiveness(such as severe acne, contact dermatitis, or purulent infection); 2. The treatment area has been treated with laser, photodynamic therapy, or other treatments that may affect the evaluation of the efficacy in 4months; 3. allergic constitution,photosensitivity, porphyria,allergy to porphyrins and its analogues; 4. scar diathesis; 5. Those who have taken photosensitive drugs in a month(such as grexomycin, thiazide diuretics, sulfonylurea, phenothiazine, sulfonamide, vitamin A, quinolone and tetracycline, etc); 6. immunocompromised conditions or need for long-term use of glucocorticoids and immunosuppressants; 7. electrocardiographic abnormalities or organic heart diseases; 8. abnormal liver function or severe renal dysfunction; 9. coagulation disorders; 10. psychiatric disease, severe endocrinopathy; 11. those who had received drug or other treatment for PWS systematically in 4 weeks; 12. those who had received drug or other treatment for PWS topically in 2 weeks; 13. Women who are pregnant, breast-feeding, or using inappropriate contraception measures; 14. Patients who have participated in other clinical trials in 4 weeks; 15. with other situations that may affect the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PWS perfusion;PWS area;PWS colour; | — |
Countries
China
Contacts
Public ContactYu Bo
Department of Dermatology and Venereology, Peking University Shenzhen Hospital
Outcome results
None listed