A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

This study has been completed.
TKL Research, Inc.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 8, 2009
Last updated: March 25, 2015
Last verified: March 2015
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Condition Intervention Phase
Actinic Keratosis
Drug: PEP005 Gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Resource links provided by NLM:

Further study details as provided by Peplin:

Primary Outcome Measures:
  • Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (complete and partial clearance of AK lesions) [ Time Frame: 57 days ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEP005 gel
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Drug: PEP005 Gel
0.05% two day treatment
Other Name: PEP005


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

Inclusion Criteria:

  • Patient is male or female and at least 18 years of age.
  • Female patient must be of either:

    • Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
    • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria

  • Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
  • Treatment with immunomodulators, 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 2 cm of the selected treatment area.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00917306

United States, Florida
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
United States, Georgia
Medaphase Inc
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
United States, Michigan
Michigan Center for Research Corp
Clinton Twp, Michigan, United States, 48038
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-4501
United States, Tennessee
Dermatology Research Associates
Nashville, Tennessee, United States, 37203
Australia, South Australia
Dematology on Ward
Adelaide, South Australia, Australia, 5006
Australia, Victoria
Dermatology Institute of Victoria
Melbourne, Victoria, Australia, 3141
Australia, Western Australia
St John of God Dermatology
Subiaco, Western Australia, Australia, 6008
Sponsors and Collaborators
TKL Research, Inc.
Study Director: Eugene Bauer, MD Chief Medical Officer
  More Information

Additional Information:
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00917306     History of Changes
Other Study ID Numbers: PEP005-020 
Study First Received: June 8, 2009
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee

Keywords provided by Peplin:
Actinic keratosis

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

ClinicalTrials.gov processed this record on April 27, 2016