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The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)

Primary Purpose

Warts

Status

Withdrawn

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

PEP005

About this trial

This is an interventional treatment trial for Warts focused on measuring PEP005, Common Wart(s), Common warts (verruca[e] vulgaris)

Eligibility Criteria

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

Inclusion Criteria:

Male and female patients at least 18 years of age.
A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand.
Written informed consent has been obtained.
Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.

Sites / Locations

South East Dermatology, 1202 Creek Rd

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm Description

Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Resolution of Common Wart(s)

Full Information

NCT ID

NCT00546611

First Posted

October 18, 2007

Last Updated

January 26, 2016

Sponsor

Peplin

1. Study Identification

Unique Protocol Identification Number

NCT00546611

Brief Title

The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)

Official Title

A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Why Stopped

No enrolement

Study Start Date

October 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peplin

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like surface, are typically slightly raised above the surrounding skin and are generally diagnosed by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05% PEP005 Topical Gel.

6. Conditions and Keywords

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

Warts

Keywords

PEP005, Common Wart(s), Common warts (verruca[e] vulgaris)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.

Intervention Type

Drug

Intervention Name(s)

PEP005

Primary Outcome Measure Information:

Title

Safety

Secondary Outcome Measure Information:

Title

Resolution of Common Wart(s)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients at least 18 years of age. A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand. Written informed consent has been obtained. Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Smith

Organizational Affiliation

Peplin Operations Pty Ltd

Official's Role

Study Director

Facility Information:

Facility Name

South East Dermatology, 1202 Creek Rd

City

Carina Heights, Brisbane

State/Province

Queensland

ZIP/Postal Code

4152

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.peplin.com

Description

Sponsor Site

URL

http://bellberry.com.au

Description

Central HREC

Learn more about this trial

The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)

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