Actinic Keratoses
Conditions
Interventions
Test Goup:Novel painless ALA-PDT
Control Group:Conventional ALA-PDT
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) No restrictions on gender, age and course of disease; 2) Lesions are located on the face, and the number of lesions on both sides of the face is not less than 1; 3) The lesion was pathologically confirmed as AK. 4) Patients were not suitable for surgery for various reasons, did not want to undergo surgery, and voluntarily participated in and signed informed consent when informed of other alternatives. They were willing to accept the protocol developed in this study and agreed to take photos of skin lesions.
Exclusion criteria
Exclusion criteria: 1) Those who had been treated with ALA-PDT within 12 weeks and those who had applied any other therapy which may have influence on this study. 2) Individuals who have facial complications that may affect the efficacy evaluation, such as other photosensitive skin diseases. 3) Those who take phototoxic or photosensitive drugs within 8 weeks; 4) It is clinically and/or pathologically proven that the tumor has invaded other organs or tissues; 5) Individuals with severe immunodeficiency; 6) Individuals with scar constitution; 7) Individuals with known skin photohypersensitivity, porphyria or allergy to ALA, light or lidocaine; 8) Those suffering from serious medical, psychological and mental diseases, infectious diseases or pregnant or lactating women;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The recurrence rate of AK during follow up;incidence of other side effects; | — |
Primary
| Measure | Time frame |
|---|---|
| The clearance rate of AK lesions at 1 month after PDT;Pain assessment; | — |
Countries
China
Contacts
Public ContactXiulli Wang
Shanghai Skin Disease Hospital
Outcome results
None listed