Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

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: NCT00375739
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : January 28, 2016
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Brief Summary:
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 Phase 2

Detailed Description:
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Double-dummy, Vehicle-controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Resolution of AK

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Male patients at least 18 years of age.
  2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
  3. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
  4. Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.
  5. Ability to follow study instructions and likely to complete all study requirements.
  6. Written informed consent has been obtained.
  7. Written Authorization for Use and Release of Health and Research Study Information has been obtained.
  8. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.


  1. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
  2. Location of the selected AK treatment area:

    1. anywhere on the face
    2. within 5 cm of an incompletely healed wound
    3. on the breast area of women
    4. on the dorsum of the hand
  3. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
  4. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.
  5. Presence of known or suspected metastatic disease.
  6. History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
  7. Known sensitivity to any of the ingredients in the study drug.
  8. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):

    • within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
  9. Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic therapy:

    • within 2 cm of the selected AK treatment area during the 24 months prior to screening visit or
    • anywhere during the 4 weeks prior to screening visit
  10. Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathiopine, chlorambucil, nitrogen mustard, methotrexate), or interferon/ interferon inducers:

    • within 4 weeks prior to screening visit
  11. Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels:

    • within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
  12. Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:

    • anywhere during the 6 months prior to screening visit
  13. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):

    • within 6 months prior to screening visit
  14. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds).
  15. Use of topical salves, artificial tanners or topical steroids:

    • On the selected AK treatment area during the 4 weeks prior to screening visit
  16. Anticipated need for hospitalization (in-patient) or surgery (except that specified in exclusion criteria 8) during the study.
  17. Concurrent disease that suppresses the immune system (e.g. HIV, hepatitis).
  18. Uncontrolled systemic disease (e.g. uncontrolled hypertension [a systolic blood pressure of 180 mmHg or greater and/or a diastolic blood pressure of 110 mmHg or greater], poorly controlled diabetes [fasting blood sugar of 350 mg/dl or greater]).
  19. Use of systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab):

    • within 4 weeks prior to screening visit
  20. Current evidence of chronic alcohol or drug abuse.
  21. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study or entry into another investigational drug or device study while enrolled in this study.
  22. A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study [e.g. patients who required hospitalization in the 2 months prior to screening for an acute or chronic condition].
  23. Selected AK treatment area within 5 cm of an AK lesion previously treated with PEP005, for those patients who have participated in earlier PEP005 topical gel trials. Patients enrolled in Treatment Phase 1 can not be re-enrolled into Treatment Phase 2.

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): NCT00375739

  Hide Study Locations
United States, Alabama
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research
Tucson, Arizona, United States, 85710
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, Florida
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, United States, 34711
Dermatology Associates and Research
Coral Gales, Florida, United States, 33134
North Florida Dermatology Associates P.A.
Jacksonville, Florida, United States, 32204
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States, 32308
Palm Beach Aesthetics
West Palm Beach, Florida, United States, 33401
United States, Georgia
Medaphase, Inc
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Centre, Inc
Snellville, Georgia, United States, 30078-3250
United States, Michigan
Henry Ford Health Center- Farmington Road
West Bloomfield, Michigan, United States, 48322
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106-5239
United States, New York
St. Luke's/Roosevelt Hospital Center Dermatology
New York, New York, United States, 10025
Mount Sinai Hospital School of Medicine
New York, New York, United States, 10029
United States, Ohio
University Dermatology Consultants, Inc., Dermatology Clinical Research Center
Cincinnati, Ohio, United States, 45219-4215
Radiant Research
Columbus, Ohio, United States, 43212
United States, Oregon
Oregon Medical Research
Centre9495 SW Locust St., Suite G Portland, Oregon, United States, 97223
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
Radiant Research
Greer, South Carolina, United States, 29651
United States, Texas
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229-3409
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
United States, Utah
Dermatology Research Centre
Salt Lake City, Utah, United States, 84124
United States, Washington
Skokane Dermatology Clinic, PLLP.
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Principal Investigator: Lawrence Anderson, Dr
Study Chair: Peter Welburn, PhD Sponsor GmbH Identifier: NCT00375739     History of Changes
Other Study ID Numbers: PEP005-006
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Peplin:
Actinic Keratosis
Solar Keratosis
Sun Spots

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