ClinicalTrials.Veeva

Menu

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

LEO Pharma logo

LEO Pharma

Status and phase

Completed
Phase 2

Conditions

Anogenital Warts

Treatments

Drug: Picato

Study type

Interventional

Funder types

Industry

Identifiers

NCT02377999
EXP-1167

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:

    2. In both sexes: inguinal, perineal, and perianal areas

    3. In men: penis shaft, scrotum, glans penis and foreskin

    4. In women: on the vulva

    1. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
    1. 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
    1. Subject suffer from any of the following conditions:

    2. Known human immunodeficiency virus (HIV) infection

    3. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment

    4. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment

    5. Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas

    1. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
    1. Prior quadrivalent HPV vaccination

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Treatment of genetial warts with Picato
Experimental group
Treatment:
Drug: Picato

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems