Extramammary Paget's disease
Conditions
Interventions
1:Hiporfin-PDT
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed as EMPD, aged 40 to 80 years (including 40 and 80 years old), male or female; 2) The patient is not suitable for surgery and rejective to undergo a surgery for any reasons, volunteered to participate in the study when informed of other alternatives, and agree to take photos of the skin lesions; 3) Without serious hematopoietic and coagulation dysfunction, heart, lung, liver and kidney dysfunction or immune deficiency; 4) Subjects with expected survival time of > 3 months; 5) After fully explaining the clinical trial drugs, the purpose and content of the study (including subjects' compliance), and on the basis of full understanding, voluntarily sign the informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients are known to be allergic to Hiporfin, ALA or related drugs; 2) Receive other anti-tumor drugs (chemoradiotherapy, immunotherapy, etc.) simultaneously during the treatment period of this study; 3) Treated with photosensitizer within 3 months before enrollment; 4) Take other photosensitizer (such as tetracycline antibiotics, sulfonamides, phenothiazines, etc.) within 4 weeks before administration; 5) Participate in any drug clinical trial (as a subject) within one month before this study; 6) Neutrophils count 3 times of normal; In the case of liver metastasis, ALT or AST>5 times the upper limit of normal value; Serum bilirubin was 3 times higher than the upper limit of normal reference range; 7) Persons are suffering from severe diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, etc.; 8) Patients infected with HIV, HCV, syphilis or hepatitis B surface antigen and e antigen are all positive; 9) Patients with acute inflammation or clinically significant active infection; 10) Pregnant or lactating women and subjects of reproductive age (including males) who refuse to take appropriate contraception during the study period; 11) Subjects in cachexia state, or late stage subjects assessed as unable to tolerate photodynamic therapy; 12) Subjects with severe physical or mental illness that the researchers believe may affect treatment, evaluation, or adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lesion area one month after the treatment;Changes in the maximum depth of lesion infiltration one month after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression disease rate of EMPD lesions one month after treatment;Recurrence time of lesion; | — |
Countries
China
Contacts
Public ContactXiuli Wang
Shanghai Skin Disease Hospital
Outcome results
None listed