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

A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)

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

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: PEP005 Topical gel

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Cohort 1 One 25 cm2 treatment area; on one arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 2; Cohort 2 One 50cm2 contiguous treatment area; on one arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 3; Cohort 3 Two 25cm2 treatment areas; one on each arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 4; Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 5; Cohort 5 One 75cm2 contiguous treatment area; on one arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 6; Cohort 6 Two 50cm2 contiguous treatment area; one on each arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 7; Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm	Drug: PEP005 Topical gel; 0.05%, two day dose
Experimental: 8; Cohort 8 One 100cm2 contiguous treatment area; on one arm	Drug: PEP005 Topical gel; 0.05%, two day dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability (incidence of AEs, SAEs and skin responses)	Screening to End of Study (Day 57)

Collaborators and Investigators

• Sponsor: Peplin
• Investigators: Principal Investigator: George Schmieder, DO, Park Avenue Dermatology; Principal Investigator: Stephen Shumack, MD, St George Dermatology and Skin and Cancer Centre

Publications and helpful links

General 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.

Helpful Links

• Therapeutic Goods Administration
• Food and Drug Administration

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: April 15, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Peplin; PEP005
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PEP005-022