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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546611
Recruitment Status : Withdrawn (No enrolement)
First Posted : October 19, 2007
Last Update Posted : January 28, 2016
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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.

Condition or disease Intervention/treatment Phase
Warts Drug: PEP005 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.
Drug: PEP005

Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Resolution of Common Wart(s)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546611

Australia, Queensland
South East Dermatology, 1202 Creek Rd
Carina Heights, Brisbane, Queensland, Australia, 4152
Sponsors and Collaborators
Study Director: Angela Smith Peplin Operations Pty Ltd

Additional Information: Identifier: NCT00546611     History of Changes
Other Study ID Numbers: PEP005-019
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Peplin:
Common Wart(s)
Common warts (verruca[e] vulgaris)

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases