NCT00427050

Brief Summary

The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 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

January 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

September 14, 2015

Status Verified

December 1, 2008

Enrollment Period

10 months

First QC Date

January 24, 2007

Last Update Submit

September 11, 2015

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses (AK)PEP005TopicalDermatology

Outcome Measures

Primary Outcomes (1)

  • Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp

Secondary Outcomes (1)

  • Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.

Interventions

PEP005DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
1. Male patients at least 18 years of age. 2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus. 3. Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp. 5\. Ability to follow study instructions and likely to complete all study requirements. 6\. Written informed consent has been obtained. 7. 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 discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Skin and Cancer Foundation

Darlinghurst, New South Wales, 2010, Australia

Location

Southderm Pty Ltd

Kogarah, New South Wales, Australia

Location

St George Dermatology and Skin Cancer Centre

Level 3, 22 Belgrave St, Kogarah, New South Wales, 2217, Australia

Location

South East Dermatology

Belmont Specialist Centre, 1202 Creek Rd, Carina Heights, Queensland, 4152, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Siller Medical

Brisbane, Queensland, Australia

Location

Auckland Dermatology

Epsom, Auckland, New Zealand

Location

Tristram Clinic

Hamilton, New Zealand

Location

Skin Centre

Tauranga, New Zealand

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 Operations Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 26, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

September 14, 2015

Record last verified: 2008-12

Locations

NZ(3)AU(6)