PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

Phase 1

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)

• Registration Number: NCT01387711
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-04
• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-12
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ingenol mebutate	PEP005 (Ingenol mebutat Gel, 0.05 %)	PEP gel 0.05% once daily exposure

Primary Outcome Measures

Name	Time	Method
Leukocytes Infiltration and degree of necrosis of the AK lesion and skin	From baseline until day 3	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

Secondary Outcome Measures

Name	Time	Method
Biological effects in the skin	from baseline till day day 3	* 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

Trial Locations

Locations (1)

Universitätsmedizin Göttingen, Georg-August-Universität; 🇩🇪 Göttingen, Germany