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

February 21, 2025 updated by: LEO Pharma
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment of genetial warts with Picato
Drug: Picato

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of incidence and severity of Local Skin Reactions (LSR)
Time Frame: Measured two weeks after every treatment and final measurement 2 weeks after last treatment
Measured two weeks after every treatment and final measurement 2 weeks after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Merete Hædersdal, Professor MD, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimated)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-1167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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