Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virus

Phase 1

• Conditions: Phase I/II study on the safety and therapeutic efficacy of repeated administration of FIT039 transdermal patch on verrucas caused by human papillomavirus

• Registration Number: JPRN-UMIN000029695
• Lead Sponsor: Department of Dermatology, Kyoto University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-01
• Study Completion: 2019-01-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Safety: Adverse events and side effects 2) Efficacy: the disappearance of warts

Secondary Outcome Measures

Name	Time	Method
1) Wart area 2) Number of petechial bleeding images