Overview

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