NCT01387711

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-07-04
• Last updated: 2025-02-24

Locations

1 site across 1 country: Germany