PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

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: NCT01387711
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 (Ingenol mebutat Gel, 0.05 %) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase I, Single-centre, Open Label, Within-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Patients With Actinic Keratosis on the Upper Extremity
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ingenol mebutate
PEP gel 0.05% once daily exposure
Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)
All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area

Primary Outcome Measures :
  1. Leukocytes Infiltration and degree of necrosis of the AK lesion and skin [ Time Frame: From baseline until day 3 ]
    Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3

Secondary Outcome Measures :
  1. Biological effects in the skin [ Time Frame: from baseline till day day 3 ]
    • Leukocytes Infiltration
    • Degree of skin infiltration of leukocytes
    • Necrosis
    • Haemorrhage
    • Immune cell activation
    • Apoptosis
    • Endothelium activation
    • RNA expression
    • Drug Transporter

    Number of participants with changes in normal skin and AK lesion biopsies

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or female patients at least 18 years of age
  2. Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
  3. Patients with a 25 cm2 area of normal skin on the upper inner arm
  4. Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
  5. Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
  6. Ability to follow study instructions and likely to complete all study requirements
  7. Obtained written informed consent prior to any study-related procedures

Exclusion Criteria:

  1. Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  2. History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
  3. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
  4. Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
  5. Current participation in any other interventional clinical trial
  6. Subjects who have received treatment with any non-marketed drug product within the last two months
  7. Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
  8. Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
  9. Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  10. Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  11. Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  12. Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
  13. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
  14. Use of systemic retinoids

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): NCT01387711

Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany, D-37075
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Michael P Schön, MD Universitätsmedizin Göttingen, Georg-August-Universität

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: LEO Pharma Identifier: NCT01387711     History of Changes
Other Study ID Numbers: LP0041-02
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016

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