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CompletedNCT00659893Updated Sep 14, 2015

Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

A Phase 1 interventional study of PEP005 Topical gel in Actinic Keratosis, sponsored by Peplin. Completed at 13 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-14.

Sponsored by Peplin · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

02

Conditions studied

  • Actinic Keratosis

Keywords

  • Peplin
  • PEP005
  • Actinic Keratosis
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 64 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
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Must be male and at least 18 years of age.
  • A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion criteria

Exclusion Criteria:

  • Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
  • Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    1

    Cohort 1 One 25 cm2 treatment area; on one arm

    Drug: PEP005 Topical gel

  • Experimental
    2

    Cohort 2 One 50cm2 contiguous treatment area; on one arm

    Drug: PEP005 Topical gel

  • Experimental
    3

    Cohort 3 Two 25cm2 treatment areas; one on each arm

    Drug: PEP005 Topical gel

  • Experimental
    4

    Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm

    Drug: PEP005 Topical gel

  • Experimental
    5

    Cohort 5 One 75cm2 contiguous treatment area; on one arm

    Drug: PEP005 Topical gel

  • Experimental
    6

    Cohort 6 Two 50cm2 contiguous treatment area; one on each arm

    Drug: PEP005 Topical gel

  • Experimental
    7

    Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm

    Drug: PEP005 Topical gel

  • Experimental
    8

    Cohort 8 One 100cm2 contiguous treatment area; on one arm

    Drug: PEP005 Topical gel

Interventions

  • DrugPEP005 Topical gel

    0.05%, two day dose

06

What researchers measure

Primary outcomes

  1. Safety and tolerability (incidence of AEs, SAEs and skin responses)

    Time frame: Screening to End of Study (Day 57)

07

Study locations

13 sites
  • Radiant Research
    Tucson, Arizona 85710, United States
  • Skin Surgery Medical Group Inc.
    San Diego, California 92117, United States
  • Park Avenue Dermatology
    Orange Park, Florida 32073, United States
  • Advanced Dermatology and Cosmetic Surgery
    Ormond Beach, Florida 32174, United States
  • Radiant Research Inc.
    Pinellas Park, Florida 33781, United States
  • Medaphase Inc
    Newnan, Georgia 30263, United States
  • Karen S. Harkaway, MD LLC
    Delran, New Jersey 08075, United States
  • J&S Studies
    College Station, Texas 77845, United States
  • St George Dematology and Skin and Cancer Centre
    Kogarah, Sydney, New South Wales 2217, Australia
  • South East Dermatology, Belmont Specialist Centre
    Carina Heights, Brisbane, Queensland 4152, Australia
  • Skin and Cancer Foundation
    Carlton, Melbourne, Victoria 3053, Australia
  • St John of God Dermatology
    Subiaco, Perth, Western Australia 6008, Australia
  • Burswood Dermatology
    Victoria Park, Perth, Western Australia 6100, Australia
08

References and documents

Publications

  • Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29. PubMed 25584134 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00659893
Lead sponsor
Peplin
Responsible party
Sponsor
First posted
Apr 17, 2008
Start date
Apr 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Sep 14, 2015

Study contacts

George Schmieder, DO
principal investigator · Park Avenue Dermatology
Stephen Shumack, MD
principal investigator · St George Dermatology and Skin and Cancer Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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