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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

October 6, 2011
July 5, 2012
September 2011
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01449513 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
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.

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.

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Actinic Keratosis
  • Drug: Ingenol mebutate
    0.05% Ingenol mebutate Gel once daily for 2 consecutive days
    Other Name: PEP005
  • Drug: Placebo Gel
    Gel vehicle of PEP005
  • Active Comparator: PEP005 Gel 0.05%
    active ingredient of PEP005: Ingenol mebutate
    Intervention: Drug: Ingenol mebutate
  • Placebo Comparator: Placebo Gel
    Vehicle of PEP005 Gel
    Intervention: Drug: Placebo Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
June 2012   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Eggert Stockfleth, Prof. Dr. med. Charite University, Berlin, Germany
LEO Pharma
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP