A Study to Examine the Safety and Toleration of PEP005 To... | NCT00544297

Studies
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand

NCT00544297

Sponsor

Peplin

Status

Completed

Last Update Posted

Apr 2, 2015Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

Actinic Keratosis

Interventions

PEP005 gel

Countries

United States

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Oct 14, 2007

First Submission Date that Met QC Criteria

Oct 15, 2007

First Posted Date

Oct 16, 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

Jul 13, 2010

Certification/Extension First Submitted that Passed QC Review

Jul 13, 2010

Certification/Extension First Posted Date

Jul 15, 2010Estimated

Last Update Submitted Date

Mar 13, 2015

Last Update Posted Date

Apr 2, 2015Estimated

Name	Class
Omnicare Clinical Research	INDUSTRY

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

The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.

Detailed Description

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEP005 gel administration	Experimental	0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand	Drug: PEP005 gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEP005 gel	Drug	Two day application, 0.05%	PEP005 gel administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)		57 days

Secondary Outcomes

Measure	Description	Time Frame
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.		57 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients at least 18 years of age.
Post-menopausal female patients
4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
Written informed consent has been obtained.
Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data 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
Arthur P Bertolino, MD	Chief Medical Officer and VP Medical Affairs	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skin Surgery Medical Group Inc		San Diego	California	92117	United States
Gwinnett Clinical Research Centre

References Module

Citations

Not provided

Label	URL
Food and Drug Administration	View source
Human Research Ethics Committee	View source

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases