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CompletedNCT00107965Updated Mar 25, 2015

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

A Phase 2 interventional study of PEP005 and PEP005 in Actinic Keratosis, sponsored by Peplin. Completed at 6 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Peplin · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

02

Conditions studied

  • Actinic Keratosis

Keywords

  • Actinic Keratosis
  • Solar Keratosis
  • AK
  • Sun spots
  • PEP005
  • Topical
  • Dermatology
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Peplin is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants

Study arms

  • Experimental
    1

    Drug: PEP005

  • Experimental
    2

    Drug: PEP005

  • Experimental
    3

    Drug: PEP005

  • Placebo comparator
    4

    Drug: PEP005

  • Experimental
    5

    Drug: PEP005

  • Experimental
    6

    Drug: PEP005

  • Experimental
    7

    Drug: PEP005

  • Placebo comparator
    8

    Drug: PEP005

Interventions

  • DrugPEP005

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

  • DrugPEP005

    0.01% PEP005 Topical Gel (Day 1,2 application)

  • DrugPEP005

    0.05% PEP005 Topical Gel (Day 1,2 application)

  • DrugPEP005

    Vehicle Gel (Day 1,2 application)

  • DrugPEP005

    0.0025% PEP005 Topical Gel (Day 1,8 application)

  • DrugPEP005

    0.01% PEP005 Topical Gel (Day 1,8 application)

  • DrugPEP005

    0.05% PEP005 Topical Gel (Day 1,8 application)

  • DrugPEP005

    Vehicle Gel (Day 1,8 application)

06

What researchers measure

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

    Time frame: 85 days

Secondary outcomes

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

    Time frame: 85 days

07

Study locations

6 sites
  • Royal Prince Alfred Hospital
    Sydney, New South Wales 2050, Australia
  • Siller Medical
    Brisbane, Queensland 4000, Australia
  • Skin and Cancer Foundation
    Melbourne, Victoria 3052, Australia
  • Monash Medical Centre
    Melbourne, Victoria 3168, Australia
  • Fremantle Dermatology
    Fremantle, Western Australia 6160, Australia
  • Private Dermaology Clinic
    Fremantle, Western Australia 6160, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00107965
Lead sponsor
Peplin
First posted
Apr 12, 2005
Start date
Mar 2005
Primary completion
Sep 2005
Completion
Sep 2005
Last update
Mar 25, 2015

Study contacts

Greg Siller
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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