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

Phase 2

Completed

• Conditions: Anogenital Warts
• Interventions: Drug: Picato

• Registration Number: NCT02377999
• Lead Sponsor: LEO Pharma

Brief Summary

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

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-05
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• 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:

  3. Known human immunodeficiency virus (HIV) infection

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

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

  6. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of genetial warts with Picato	Picato	-

Primary Outcome Measures

Name	Time	Method
Number of incidence and severity of Local Skin Reactions (LSR)	Measured two weeks after every treatment and final measurement 2 weeks after last treatment

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark