Clinical trial NCT01387711: PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
timeFrame: From baseline until day 3
Secondary outcomes:
measure: Biological effects in the skin
timeFrame: from baseline till day day 3
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
Study officials:
affiliation: Universitätsmedizin Göttingen, Georg-August-Universität
name: Michael P Schön, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emmert S, Haenssle HA, Zibert JR, Schon M, Hald A, Hansen MH, Litman T, Schon MP. Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate. PLoS One. 2016 Sep 9;11(9):e0160096. doi: 10.1371/journal.pone.0160096. eCollection 2016.