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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)

This study has been withdrawn prior to enrollment.
(No enrolement)
Information provided by:
Peplin Identifier:
First received: October 18, 2007
Last updated: January 26, 2016
Last verified: January 2016
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 Intervention Phase
Warts Drug: PEP005 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Peplin:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Resolution of Common Wart(s)

Enrollment: 0
Study Start Date: October 2007
Arms Assigned Interventions
Active Comparator: 1
Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.
Drug: PEP005


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information: Identifier: NCT00546611     History of Changes
Other Study ID Numbers: PEP005-019
Study First Received: October 18, 2007
Last Updated: January 26, 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 processed this record on August 22, 2017