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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

Criteria

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