actinic keratosis
Conditions
Interventions
Retinoic acid capsules+photodynamic therapy:The combination of tretinoin capsules and photodynamic therapy group received daily fixed time administration of ATRA orally at a dose of 10mg bid for 12 we
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age range: 18-85 years old (including 18 and 85 years old), gender is not limited; (2) AK patients diagnosed by histopathology, clinically diagnosed as AK (OLSEN grading: I, II, and III); (3) The subject has at least 4 or more clinically visible and discrete AK skin lesions; (4) All patients were determined by the researchers not to consider surgery and were willing to accept the protocol developed in this study, and agreed to have their skin lesions photographed; (5) The functions of important organs meet the following requirements: Absolute neutrophil count = 1.5 × 109/L Platelets = 80 × 109/L; Hemoglobin = 90 g/L Serum albumin = 30g/L Bilirubin = 1.5 × ULN ALT and AST = 1.5 × ULN Serum creatinine = 1.5 × ULN Total cholesterol = 1.5 × ULN Triglycerides = 1.5 × ULN (6) Women with reproductive potential must undergo a negative serum pregnancy test within 72 hours before the start of the study drug. Postmenopausal women (defined as those who have not had menstruation for at least one year) and women who have undergone surgical sterilization do not need to undergo pregnancy testing; (7) Patients with fertility potential (male and female) must agree to use appropriate contraceptive measures, starting from the signing of the consent form and continuing for at least one month after the last dose of the study medication. The definition of appropriate contraception will be based on the judgment of the primary researcher or designated assistant; (8) Can comply with the research visit schedule and understand and adhere to all trial protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Use any other medication or treatment for AK within 12 weeks; (2) Those who have taken phototoxic or photosensitive drugs within 8 weeks; (3) Researchers believe that a history of skin conditions other than the trial indications that interfere with the evaluation of the investigational drug (such as eczema, cutaneous lupus erythematosus, pemphigus vulgaris, erythematous pemphigus, etc.); (4) Patients with a history of confirmed cSCC within 12 months; (5) Individuals known to have skin photosensitivity, porphyria, or allergies to ALA, light, or lidocaine; (6) Known allergy to all trans retinoic acid; (7) There are multiple factors that can affect oral medication, such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction; (8) Individuals who test positive for hepatitis B or C virus during screening; (9) Patients with a history of abuse of psychotropic drugs who are unable to quit or those with mental disorders; (10) As a participant in clinical trials of other drugs, the last administration of the investigational drug was less than 4 weeks after the first administration of the study drug; (11) According to the researcher's judgment, it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate of AK lesions in subjects who were completely cleared at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with complete clearance of AK at week 12;Percentage of subjects with partially clearance of AK at week 12;Safety evaluation;Exploratory endpoint; | — |
Countries
China
Contacts
Public Contactyongfeng chen
Dermatology Hospital of Southern Medical University
Outcome results
None listed