Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01387711
First received: July 1, 2011
Last updated: July 5, 2012
Last verified: July 2012

July 1, 2011
July 5, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
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
Leukocytes Infiltration AK lesion [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
Degree of skin infiltration of leukocytes in haematoxylin & eosin-stained sections assessed on a scale from 0 to 3 in the AK biopsies from baseline, Day 2, and Day 3. Degree of necrosis of the epidermis and dermis in haematoxylin & eosin-stained sections assessed as binary outcome (present/absent) in the AK biopsies from Day 1, Day 2, and Day 3
Complete list of historical versions of study NCT01387711 on ClinicalTrials.gov Archive Site
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

  • Leukocytes Infiltration normal Skin [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Degree of skin infiltration of leukocytes in haematoxylin & eosin-stained sections assessed on a scale from 0 to 3 in the normal skin biopsies from day 3 compared to baseline and to AK lesion biopsies
  • Necrosis normal Skin [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Degree of necrosis of the epidermis and dermis in haematoxylin & eosin-stained sections assessed as binary outcome (present/absent) in the normal skin biopsies from day 3 compared to baseline and to AK lesion biopsies
  • Haemorrhage [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Degree of haemorrhage assessed by histology(binary outcome present/absent) in the Normal skin and AK lesion biopsies at all time points
  • Immune cell activation [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Characterisation of immune cells such as T and B lymphocytes, polymorphonuclear cells, mast cells and antigen presenting cells in the Normal skin and AK lesion biopsies
  • Apoptosis [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Degree of apoptosis in the Normal skin and AK lesion biopsies
  • Endothelium activation [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Degree of vascular endothelium activation in the Normal skin and AK lesion biopsies
  • RNA expression [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Changes in mRNA and miRNA expression in the Normal skin and AK lesion biopsies
  • Drug Transporter [ Time Frame: From baseline until day 3 ] [ Designated as safety issue: No ]
    Expression of drug transporters in the Normal skin and AK lesion biopsies (P-gP)
Not Provided
Not Provided
 
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Actinic Keratosis
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01387711
LP0041-02
No
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Michael P Schön, MD Universitätsmedizin Göttingen, Georg-August-Universität
LEO Pharma
July 2012

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