PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

Phase 1

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Placebo Gel; Drug: Ingenol mebutate

• Registration Number: NCT01449513
• 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 reflectance confocal microscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-10-08
• Results First Submitted QC: 2015-05-06
• Results First Posted: 2015-05-27
• Status Verified: 2016-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Gel	Placebo Gel	Vehicle of PEP005 Gel
PEP005 Gel 0.05%	Ingenol mebutate	active ingredient of PEP005: Ingenol mebutate

Primary Outcome Measures

Name	Time	Method
Change in Degree of Infiltration	Baseline to Day 57	Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin; The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel.
Change in Degree of Necrosis	Baseline to Day 57	Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany