Skin Warts
Conditions
Interventions
Group 1:5% Drug concentration applied for 15 minutes. 450nm laser 80mW/cm^2 light power density for 1000s or self-placebo control
Group 2:10% Drug concentration applied for 15 minutes. 450nm laser 80mW/cm^2 light power density for 600s or self-placebo control
Group 3-1:10% Drug concentration applied for 15 minutes. 450nm laser 80mW/cm^2 light power density for 1000s or self-placebo control
Group 3-2:10% Drug concentration applied for 15 minutes. 450nm laser 80mW/cm^2 light power density for 1000s or self-placebo control
Group 4:20% Drug concentration applied for 15 minutes. 450nm laser 80mW/cm^2 light power density for 1000s or self-placebo control
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Willing to voluntarily participate and provide signed and dated informed consent. 2. Male or female subjects aged 18 to 65 years (inclusive). 3. Male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg. Body mass index (BMI) must be between 16 and 30 kg/m² (inclusive). 4. Diagnosed with skin warts, including common warts or flat warts (for periungual warts, only warts that do not involve the subungual area will be treated and evaluated). 5. At least one, and no more than ten, warts within the 3 cm treatment area intended for drug application and light exposure, meeting the following criteria: a. Each individual wart or fused wart must have a longest diameter between 1 mm and 10 mm (for common warts) at screening and baseline. b. Each wart or fused wart must be an independent lesion, with at least 5 mm of separation from adjacent warts. c. The wart(s) must have been present for at least 4 weeks. d. The treatment area must be located on the face/neck, back, upper limbs (including hands), or lower limbs (excluding feet). 6. Willing to provide photographs of the treatment area. 7. For female subjects: a. No reproductive potential, including a documented history of surgical sterilization at least 6 weeks prior to the screening visit (e.g., tubal ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal status for at least 12 months before the screening visit (as confirmed by a follicle-stimulating hormone (FSH) level >= 40 IU/L); or b. With reproductive potential, the subject must not be pregnant or breastfeeding and must agree to use non-drug contraception for at least 30 days prior to the first dose, throughout the study period, and for 3 months after the last dose. The subject must have a negative serum human chorionic gonadotropin (hCG) test at the screening visit. The subject must also agree not to donate eggs during this time. 8. Male subjects with partners of childbearing potential must agree to use highly effective, non-drug contraception for at least 14 days prior to the first dose, throughout the study period, and for 3 months after the last dose. The subject must agree not to donate sperm during this time. 9. Willing to comply with the study visit schedule, study treatments, laboratory tests, and other study-related procedures and requirements.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following criteria: 1. Allergy to the investigational drug or its excipients, or allergy to the blue light source, or a history of severe allergies (including any food or drug allergies). 2. A history of photosensitivity disorders such as actinic prurigo, polymorphic light eruption, solar urticaria, chronic actinic dermatitis, porphyria, etc., or suspected photosensitivity as assessed by the investigator. 3. Suffering from epidermodysplasia verruciformis, suspected precancerous lesions, or skin cancer. 4. Presence of skin diseases other than warts, or a history of recurrent skin infections, and the investigator deems the condition could affect the study or pose unacceptable risks to the subject. 5. The treatment area shows sensitivity, infection, inflammation, redness, rash, sunburn, blisters, damage, trauma, pigmentation changes, or presents symptoms like pain, itching, numbness, birthmarks, pigmented moles, tattoos, or scars. 6. Sunbed tanning within 48 hours before the planned treatment. 7. Clinically significant abnormalities in vital signs, physical examination, or laboratory tests (excluding flat and common warts). 8. Clinically significant abnormalities in the 12-lead ECG. 9. A history of psychiatric disorders, family history of psychiatric disorders, or a history of chronic or serious diseases affecting the central nervous system, cardiovascular, liver, kidney, lungs, digestive, metabolic, hematological, or skeletal systems, as assessed by the investigator. 10. Positive for HIV antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV-Ab), or Treponema pallidum antibodies (TP-Ab). 11. Received local or systemic treatment for warts in the treatment area (and surrounding 5 cm skin) within 1 month before the first administration, or received an HPV vaccine within 6 months before the first administration. 12. Active autoimmune disease or a history of autoimmune diseases requiring systemic treatment within 2 years before screening. 13. Uncontrolled bacterial, viral, fungal, or other pathogen infections (such as mycoplasma, parasites, etc.) within 1 month before the first administration, requiring systemic treatment. 14. Immunosuppressive therapy (e.g., corticosteroids, methotrexate, cyclosporine) within 1 month before the first administration, excluding topical, ocular, intra-articular, intranasal, or inhaled corticosteroids. 15. Use of any prescription or over-the-counter drugs, herbal medicines, or supplements within 14 days before the first administration, or use of phototoxic or photosensitive drugs (e.g., hypericin, quinolones, glibenclamide, glipizide, sulfonamides, tetracyclines, chloramphenicol, phenothiazines) within 3 months before the first administration. 16. Known or suspected history of substance abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC acid, cocaine), or positive drug abuse screening. 17. Alcohol abuse within 1 year before screening (defined as consuming more than 21 units of alcohol per week; one unit contains 14g of alcohol, e.g., 360 mL of 5% beer, 45 mL of 40% liquor, or 120 mL of 12% wine), or positive breath alcohol test before the first administration. 18. Smoking more than 5 cigarettes per day within 3 months before screening, or use of nicotine products within 7 days before the first administration, or inability to comply with smoking restrictions during the study. 19. Participation in another clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local skin reactions at the application site;adverse events (AEs);physical exams;Vital Signs;laboratory tests(complete blood count, biochemistry, coagulation function, serology, and urinalysis);12-Lead ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters such as maximum concentration (Cmax), time to peak concentration (Tmax), area under the curve from 0 to the last measurable concentration (AUC0-t), and area under the curve from 0 to infinity (AUC0 8);Device defects related to the semiconductor laser therapy device;Proportion of target lesions completely cleared;For common warts: Proportion of target lesions with a reduction in wart area (limited to cases where wart thickness remains the same or decreases) of = 70% but = 70% but < 100%;For common warts: Proportion of target lesions with a reduction in wart thickness of less than 70%;Number of treatments required to completely clear a single target lesion;Time to complete clearance of a single target lesion; | — |
Countries
China
Contacts
Public ContactHang Li; Yimin Cui
Peking University First Hospital
Outcome results
None listed