NCT00544258

Brief Summary

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 12, 2015

Status Verified

May 1, 2008

Enrollment Period

7 months

First QC Date

October 14, 2007

Last Update Submit

February 11, 2015

Conditions

Actinic Keratoses

Keywords

Pharmacokinetic studyActinic KeratosisTopicalDermatology

Outcome Measures

Primary Outcomes (1)

  • To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Secondary Outcomes (1)

  • To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Study Arms (1)

1

EXPERIMENTAL

Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.

Drug: PEP005

Interventions

PEP005DRUG
1

Eligibility Criteria

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

You may qualify if:

  • Male patients at least 18 years of age.
  • A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
  • 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 package.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siller Medical

Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, 4000, Australia

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janelle Katsamas

    Peplin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2007

First Posted

October 16, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 12, 2015

Record last verified: 2008-05

Locations

AU(1)