NCT00107965

Brief Summary

The purpose of this study is to determine whether topical application of PEP005 is safe 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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

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

March 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

April 11, 2005

Last Update Submit

March 24, 2015

Conditions

Actinic Keratosis

Keywords

Actinic KeratosisSolar KeratosisAKSun spotsPEP005TopicalDermatology

Outcome Measures

Primary Outcomes (1)

  • To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp

    85 days

Secondary Outcomes (1)

  • To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses

    85 days

Study Arms (8)

1

EXPERIMENTAL
Drug: PEP005

2

EXPERIMENTAL
Drug: PEP005

3

EXPERIMENTAL
Drug: PEP005

4

PLACEBO COMPARATOR
Drug: PEP005

5

EXPERIMENTAL
Drug: PEP005

6

EXPERIMENTAL
Drug: PEP005

7

EXPERIMENTAL
Drug: PEP005

8

PLACEBO COMPARATOR
Drug: PEP005

Interventions

PEP005DRUG

0.0025% PEP005 Topical Gel (Day 1,2 application)

1

Eligibility Criteria

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

You may qualify if:

  • Male or female patients
  • At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

You may not qualify if:

  • A cosmetic or therapeutic procedure:
  • within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
  • Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
  • of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
  • Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
  • Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
  • Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
  • Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
  • Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
  • Females of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Siller Medical

Brisbane, Queensland, 4000, Australia

Location

Skin and Cancer Foundation

Melbourne, Victoria, 3052, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Private Dermaology Clinic

Fremantle, Western Australia, 6160, Australia

Location

MeSH Terms

Conditions

Keratosis, ActinicMelanosis

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesHyperpigmentationPigmentation Disorders

Study Officials

  • Greg Siller

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2005

First Posted

April 12, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

AU(6)