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

Sponsored by:	Peplin
Information provided by:	Peplin
ClinicalTrials.gov Identifier:	NCT00546611

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 I

MedlinePlus related topics: Warts

Drug Information available for: 3-ingenyl angelate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety Study
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

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
1: Active Comparator 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

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

Sponsor Site This link exits the ClinicalTrials.gov site

Central HREC This link exits the ClinicalTrials.gov site

Study ID Numbers:	PEP005-019
Study First Received:	October 18, 2007
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00546611
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)

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Warts

Skin Diseases
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009