Phase I/II study on the safety and therapeutic efficacy of repeated administration of FIT039 transdermal patch on verrucas caused by human papillomavirus
Conditions
Interventions
Apply one study drug once a day for 14 days to the wart area after a cryotherapy
Apply one placebo once a day for 14 days to the wart area after a cryotherapy
Sponsors
Department of Dermatology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women who meet the following criteria: 1. Having verruca vulgaris, measuring 4 to 10 mm on the major axis, on the extremities, including the palms and soles. 2. Aged over 20 years old at the time of consent. 3. Blood test within 4 weeks prior to the registration fulfills all of the followings: hemoglobin level = or > 10 g/dL, white blood cell count = or > 2,000/microL, platelet count = or > 100,000/microL, AST/GOT = or < 100 IU/L, ALT/GPT = or > 100 IU/L, total bilirubin = or < 2.0 mg/dL, and serum creatinine = or < 2.0 mg/dL. 4. All men have agreed to use proper contraception during the entire FIT039-patch application period and for seven days after. 5. All women must satisfy one of the followings and have no possibility of being pregnant; in menopause, with 12 months or more having passed since the last menstruation without pathological reason, or having undergone permanent contraceptive surgery in the past, such as bilateral oophorectomy and bilateral ligation of the fallopian tubes. 6. Willing to participate in the study. Written informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: Men and women who meet the following criteria are excluded: 1. Allergic to transdermal patches. 2. Having one of the following complications: serious heart disease, gastrointestinal disease, liver disease, kidney disease, systemic skin disorders with lesions at the target verruca vulgaris, uncontrolled diabetes mellitus, infectious diseases requiring continuous treatment by injection or oral application of medical agents, or diseases requiring continuous systemic administration of immunosuppressants or steroids. 3. Having an active malignancy, excluding conditions such as, adequately treated basal cell carcinoma, intraepithelial carcinoma, or superficial bladder carcinoma, or a malignant tumor not showing metastasis or recurrence for 5 years or more from the end of treatment. 4. Having other verruca vulgaris warts within 1 cm from the target wart. 5. Having been treated with cryotherapy for the target wart within 4 weeks prior to the acquisition of written consent. 6. Taking general antiviral drugs within 4 weeks prior to the acquisition of the written consent. 7. Participating in other trials within 4 weeks prior to the acquisition of the written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety: Adverse events and side effects 2) Efficacy: the disappearance of warts | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Wart area 2) Number of petechial bleeding images | — |
Countries
Japan
Contacts
Public ContactTakashi Nomura
Kyoto University Hospital Department of dermatology
Outcome results
None listed