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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917306
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : April 15, 2015
TKL Research, Inc.
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) [ Time Frame: 57 days ]

Secondary Outcome Measures :
  1. Efficacy (complete and partial clearance of AK lesions) [ Time Frame: 57 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917306

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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.
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Study Director: Eugene Bauer, MD Chief Medical Officer

Additional Information:
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Responsible Party: Peplin Identifier: NCT00917306     History of Changes
Other Study ID Numbers: PEP005-020
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: March 2015

Keywords provided by Peplin:
Actinic keratosis

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