NCT00544297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

October 14, 2007

Last Update Submit

March 13, 2015

Conditions

Actinic Keratosis

Keywords

Actinic KeratosisTopicalDermatologyHand

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)

    57 days

Secondary Outcomes (1)

  • The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.

    57 days

Study Arms (1)

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

PEP005 gelDRUG

Two day application, 0.05%

Also known as: PEP005
PEP005 gel administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients at least 18 years of age.
  • Post-menopausal female patients
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Skin Surgery Medical Group Inc

San Diego, California, 92117, United States

Location

Gwinnett Clinical Research Centre

Snellville, Georgia, 30078-3250, United States

Location

Dermatology Clinical Research Centre of San Antonio

San Antonio, Texas, 78229-3409, United States

Location

Dermatology Associates of Tyler

Tyler, Texas, 75703, United States

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Arthur P Bertolino, MD

    Chief Medical Officer and VP Medical Affairs

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2007

First Posted

October 16, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

US(4)