Verruca vulgaris
Conditions
Interventions
Single application of adhesive skin patch containing FIT039
Sponsors
Department of Dermatology, Kyoto University Hospital Department of Anatomy and Developmental Biology, Kyoto University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. V erruca vulgaris developed on extremities and scheduled to be treated with cryotherapy 2. Women,who have no possibility for pregnancy and suffice one of the followings; that being aged 60 years or more at the time of issuing informed consent, that being elapsed more than 12 months from the last menstrual and determined to be menopausal, or that being operated with bilateral oophorectomy 3. The latest laboratory data, given within four weeks prior to the enrollment, sufficing the following; hemoglobin >= 8 g/dL, white blood cells >= 2,000/dL, platelets >= 70,000/dL, AST (GOT) <= 100 IU/L, ALT (GPT) <= 100 IU/L, total bilirubin <= 1.5 mg/dL, serum creatinine <= 2.0 mg/dL 4. Written consent with respect to the participation in this study is obtained from the patient himself or herself
Exclusion criteria
Exclusion criteria: 1. One who has allergy to adhesive skin patch 2. One who has at least one of the complications as follows: severe complications of heart disease, respiratory disease, gastrointestinal disease, liver disease, or renal disease; dermal diseases except atopic dermatitis and verruca vulgaris; poorly controlled diabetes mellitus; infection requiring continuous treatment; diseases that require systemic administration of immunosuppressant or steroids 3. Carrying malignancy in an active state 4. Taking antiviral agent within four weeks prior to the time of obtaining informed consent 5. Being enrolled in other clinical study within four weeks prior to the time of obtaining informed consent 6. Any patient, who was determined by the principal investigator or the physician in charge to be inadequate safely to conduct the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse and side effects at 30 minutes, 2 hours, 4 hours, 1 day, and 7 days after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events and side effects for each undesirable event Kinetics of FIT039 concentration in peripheral blood Surface area of verruca vulgaris lesion Changes of vital signs | — |
Countries
Japan
Contacts
Public ContactTakashi Nomura
Kyoto University Hospital Department of Dermatology
Outcome results
None listed