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NCT00546611 Clinical Trial

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

Warts Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00546611
Other study ID # PEP005-019
Secondary ID
Status Withdrawn
Phase Phase 1
First received October 18, 2007
Last updated January 26, 2016
Start date October 2007

Study information
Verified date January 2016
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PEP005

Locations
Country Name City State
Australia South East Dermatology, 1202 Creek Rd Carina Heights, Brisbane Queensland

Sponsors (1)
Lead Sponsor Collaborator
Peplin

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Secondary Resolution of Common Wart(s)
See also
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Active, not recruiting NCT00254280 - Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial N/A
Completed NCT04781244 - Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment N/A
Completed NCT01101750 - Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls? Phase 4
Completed NCT03487549 - Cantharidin and Occlusion in Verruca Epithelium Phase 2
Recruiting NCT05625633 - Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts Phase 2/Phase 3
Completed NCT02393417 - Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris) Phase 2
Completed NCT01808443 - Efficacy of Laser Versus Cryotherapy in the Treatment of Warts N/A
Completed NCT00116675 - Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2
Completed NCT00116662 - An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2
Completed NCT00114920 - Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults Phase 2

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