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

Primary Purpose

Anogenital Warts

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Picato

About this trial

This is an interventional treatment trial for Anogenital Warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of genetial warts with Picato

Arm Description

Outcomes

Primary Outcome Measures

Number of incidence and severity of Local Skin Reactions (LSR)

Secondary Outcome Measures

Full Information

NCT ID

NCT02377999

First Posted

February 20, 2015

Last Updated

May 1, 2017

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02377999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anogenital Warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment of genetial warts with Picato

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Picato

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: In both sexes: inguinal, perineal, and perianal areas In men: penis shaft, scrotum, glans penis and foreskin 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: Known human immunodeficiency virus (HIV) infection An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Hædersdal, Professor MD

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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