The Purpose of This Study is to Determine Whether Topical... | NCT00546611

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

NCT00546611

Sponsor

Peplin

Status

Withdrawn

Last Update Posted

Jan 28, 2016Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Warts

Interventions

PEP005

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No enrolement

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 2007

First Submission Date that Met QC Criteria

Oct 18, 2007

First Posted Date

Oct 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.	Drug: PEP005

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEP005	Drug		1

Measure	Description	Time Frame
Safety

Measure	Description	Time Frame
Resolution of Common Wart(s)

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela Smith	Peplin Operations Pty Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South East Dermatology, 1202 Creek Rd		Carina Heights, Brisbane	Queensland	4152	Australia

Label	URL
Central HREC	View source

Condition Browse Module

MeSH Terms

ID	Term
D014860	Warts

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C486592	3-ingenyl angelate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided