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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anogenital Warts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment of genetial warts with Picato

Group Type EXPERIMENTAL

Picato

Intervention Type DRUG

Interventions

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Picato

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No