NCT00546611

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

First QC Date

October 18, 2007

Last Update Submit

January 26, 2016

Conditions

Warts

Keywords

PEP005Common Wart(s)Common warts (verruca[e] vulgaris)

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Resolution of Common Wart(s)

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: PEP005

Interventions

PEP005DRUG
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South East Dermatology, 1202 Creek Rd

Carina Heights, Brisbane, Queensland, 4152, Australia

Location

Related Links

MeSH Terms

Conditions

Warts

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Angela Smith

    Peplin Operations Pty Ltd

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

October 1, 2007

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

AU(1)