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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00546611
First received: October 18, 2007
Last updated: February 13, 2008
Last verified: February 2008
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Estimated Enrollment: 12
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00546611

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00546611     History of Changes
Other Study ID Numbers: PEP005-019
Study First Received: October 18, 2007
Last Updated: February 13, 2008
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Peplin:
PEP005
Common Wart(s)
Common warts (verruca[e] vulgaris)

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

ClinicalTrials.gov processed this record on October 29, 2014