PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

This study has been completed.
Information provided by (Responsible Party):
LEO Pharma Identifier:
First received: October 6, 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 reflectance confocal microscopy.

Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate
Drug: Placebo Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase I, Two-stage, Single-centre, Open Label, Within- and Between-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Subjects With Actinic Keratosis on the Upper Extremity. A Single-arm First Stage Followed by a Two-arm, Parallel Group, Randomized, Placebo (Vehicle) -Controlled Second Stage.

Resource links provided by NLM:

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Degree of infiltration and necrosis of epidermis and dermis [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]
    Change in the degree of skin infiltration by inflammatory cells and degree of necrosis following treatment with PEP005 Gel, 0.05% as assessed by RCM.

Secondary Outcome Measures:
  • Leucocyte infiltration [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]
  • Degree of necrosis [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]
  • Changes in pigmentation, solar elastosis and fibrosis [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]
  • Confirmation of subclinical AK [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]
  • AK clearance [ Time Frame: From baseline till day 57 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEP005 Gel 0.05%
active ingredient of PEP005: Ingenol mebutate
Drug: Ingenol mebutate
0.05% Ingenol mebutate Gel once daily for 2 consecutive days
Other Name: PEP005
Placebo Comparator: Placebo Gel
Vehicle of PEP005 Gel
Drug: Placebo Gel
Gel vehicle of PEP005


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

Inclusion Criteria:

  1. Male or female subjects at least 18 years of age
  2. Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity
  3. Subjects must have a 25 cm2 area of normal skin on the inner upper arm
  4. Female subjects must be of either:• Non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • Childbearing potential, with a confirmed negative urine pregnancy test prior to exposure.
  5. Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
  6. Ability to follow trial instructions and likely to complete all trial requirements
  7. Obtained written informed consent prior to any trial-related procedures

Exclusion Criteria:

  1. Location of the selected treatment areas:• Within 5 cm of an incompletely healed wound or infected area of the skin • 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 trial indication that would interfere with evaluation of the investigational product
  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 during the course of the trial, as determined by Investigator clinical judgment
  4. Anticipated need for in-patient hospitalisation or in-patient surgery during the trial 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. Previous enrolment in this clinical trial
  8. Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2 cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of acid-containing therapeutic products • Use of topical salves or topical steroids
  9. Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit: • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with UVB
  10. Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit: • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas.
  11. Use of systemic retinoids
  Contacts and Locations
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Please refer to this study by its identifier: NCT01449513

Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Eggert Stockfleth, Prof. Dr. med. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: LEO Pharma Identifier: NCT01449513     History of Changes
Other Study ID Numbers: LP0041-03
Study First Received: October 6, 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 May 21, 2015