Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts

The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.

Inclusion criteria

• 1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:

• In both sexes: inguinal, perineal, and perianal areas
• In men: penis shaft, scrotum, glans penis and foreskin
• In women: on the vulva
• 2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
• 3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment

Exclusion criteria

• 1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
• 2. Subject suffer from any of the following conditions:

• Known human immunodeficiency virus (HIV) infection
• An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
• Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
• Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
• 3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
• 4. Prior quadrivalent HPV vaccination