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CompletedNCT02377999Updated Feb 24, 2025

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

A Phase 2 interventional study of Picato in Anogenital Warts, sponsored by LEO Pharma. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anogenital Warts

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03

In context

Condylomata Acuminata

97 studies on the registry are indexed under Condylomata Acuminata; 8 are open to participants now.

This study's enrollment of 40 is below the median of 140 across 79 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment of genetial warts with Picato

    Drug: Picato

Interventions

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen NV, 2400, Denmark
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2015
First posted
Mar 4, 2015
Start
Feb 2015
Primary completionActual
Nov 2015
CompletionActual
Nov 2015
Last update
Feb 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02377999
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Mar 4, 2015
Start date
Feb 2015
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 24, 2025

Study contacts

Merete Hædersdal, Professor MD
principal investigator · Bispebjerg Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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