- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00546611
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)
January 26, 2016 updated by: Peplin
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
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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Carina Heights, Brisbane, Queensland, Australia, 4152
- South East Dermatology, 1202 Creek Rd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1
Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety
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Secondary Outcome Measures
Outcome Measure |
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Resolution of Common Wart(s)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Angela Smith, Peplin Operations Pty Ltd
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Registration Dates
First Submitted
October 18, 2007
First Submitted That Met QC Criteria
October 18, 2007
First Posted (Estimate)
October 19, 2007
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP005-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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