actinic keratosis
Conditions
Interventions
Experimental group :Administer different investigational medicinal products at varying doses
Placebo group:Administer placebo at different doses according to dosage
Sponsors
Shanghai skin disease hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with actinic keratosis by histopathology, Olsen grade I or II; 2. Age >=18 years, any gender; 3. Able to delineate a treatment area on the face of 100 cm^2 covering clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral area, eyelids, periorbital area, inside and around the nostrils, and inner ear canal); 4. Willing to avoid direct sunlight or UV exposure to the treatment area during the study; 5. Female participants of childbearing potential must have a negative pregnancy test; male and female participants must have no plans for pregnancy from the time of signing the informed consent form until 3 months after the last dose, and agree to use medically accepted reliable contraception; participants may not donate sperm or eggs from the time of signing the informed consent form until 3 months after the last dose; 6. Fully understands this study, voluntarily signs the informed consent form, and is able to comply with study procedures and follow-up examination requirements.
Exclusion criteria
Exclusion criteria: 1. The following conditions exist within the treatment area: (1) Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions and/or cutaneous horns; (2) A single lesion with a maximum diameter greater than 2 cm; (3) A history of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors; (4) Presence of other skin diseases or conditions that may make examination or evaluation difficult; 2. The treatment area is located in the following situations: (1) There is an incompletely healed wound within 5 cm of the area; (2) There is a suspected squamous cell carcinoma, basal cell carcinoma, or other tumor within 5 cm of the area; 3. Subjects have other skin diseases (such as atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (such as tattoos, birthmarks, ulceration, scars, open wounds, etc.) that the investigator believes may interfere with the assessment of safety or efficacy; 4. Subjects have severe cardiovascular or cerebrovascular diseases, such as chronic heart failure classified as NYHA class III-IV, uncontrolled hypertension (systolic =160 mmHg or diastolic =100 mmHg), uncontrolled arrhythmias, or unstable angina; or have experienced a myocardial infarction, acute stroke, coronary artery bypass surgery, etc., within 6 months prior to screening; 5. Electrocardiogram abnormalities with significant clinical implications, such as QTc interval >= 450 ms, long QT syndrome, etc.; 6. Clinically important laboratory test abnormalities, including: (1) Abnormal complete blood count: hemoglobin (Hb) = 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) >= 2 × ULN, or alkaline phosphatase >= 2 × ULN, or total bilirubin >= 1.5 × ULN; (3) Abnormal renal function: creatinine (Cr) >= 2 × ULN; (4) Other laboratory test abnormalities that the investigator considers may affect the evaluation of trial results; 7. Active and uncontrolled viral infections at screening, such as HIV, HBV (HBsAg positive), HCV (anti-HCV antibody or HCV-RNA positive), syphilis, etc., or any bacterial, viral, parasitic, or fungal infections with clinical symptoms that require treatment; 8. Systemic treatment for actinic keratosis within 6 months prior to screening; 9. Topical medication or non-drug treatment for actinic keratosis in the treatment area within 3 months prior to screening; 10. Any surgical procedure within 3 months prior to screening, or planning to undergo surgery during the trial; 11. Individuals who have received a live (attenuated) vaccine within 2 months prior to screening; 12. Individuals who have taken drugs known to strongly induce or inhibit liver metabolism via CYP3A4 and CYP2C19 enzymes within 1 month prior to screening; 13. Individuals who have consumed excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to screening; 14. Individuals who smoke more than 5 cigarettes per day within 3 months prior to screening or cannot stop smoking while staying in the Phase I ward; 15. Individuals who regularly consume alcohol within 3 months prior to screening, with weekly alcohol intake exceeding 14 units (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Area Under the Curve, AUC;Tmax;t1/2;Amount excreted in urine, Ae;Fraction excreted, Fe;Incidence of local skin reactions; | — |
Countries
China
Contacts
Public ContactZhang Guolong
Shanghai Skin Disease Hospital
Outcome results
None listed