PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387711
• Other study ID #: LP0041-02
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2011
• Last updated: December 1, 2016
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2016
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsmedizin Göttingen, Georg-August-Universität	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukocytes Infiltration and degree of necrosis of the AK lesion and skin	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	From baseline until day 3	No
Secondary	Biological effects in the skin	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	from baseline till day day 3	No

External Links

•   Clinical Trials at LEO Pharma