PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

This study has been completed.
Information provided by (Responsible Party):
LEO Pharma Identifier:
First received: July 1, 2011
Last updated: July 5, 2012
Last verified: July 2012
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 Intervention Phase
Actinic Keratosis
Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Leukocytes Infiltration and degree of necrosis of the AK lesion and skin [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    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:
  • Biological effects in the skin [ Time Frame: from baseline till day day 3 ] [ Designated as safety issue: No ]
    • 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

Enrollment: 27
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: LEO Pharma Identifier: NCT01387711     History of Changes
Other Study ID Numbers: LP0041-02 
Study First Received: July 1, 2011
Last Updated: July 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Keratosis, Actinic
Precancerous Conditions
Skin Diseases processed this record on February 07, 2016