An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.

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:

  1. In both sexes: inguinal, perineal, and perianal areas
  2. In men: penis shaft, scrotum, glans penis and foreskin
  3. 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:

  1. Known human immunodeficiency virus (HIV) infection
  2. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
  3. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
  4. 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