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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00659893
First received: April 15, 2008
Last updated: November 4, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention Phase
Actinic Keratosis
Drug: PEP005 Topical gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Peplin:

Primary Outcome Measures:
  • Safety and tolerability (incidence of AEs, SAEs and skin responses) [ Time Frame: Screening to End of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659893

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

Additional Information:
No publications provided

Responsible Party: Janelle Katsamas, Peplin Operations Pty Ltd
ClinicalTrials.gov Identifier: NCT00659893     History of Changes
Other Study ID Numbers: PEP005-022
Study First Received: April 15, 2008
Last Updated: November 4, 2008
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Peplin:
Peplin
PEP005
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 20, 2014