NCT01449513

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

A Phase 1, Two-stage, Single-centre, Open Label, Within- and Between-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Subjects With Actinic Keratosis on the Upper Extrem-ity. A Single-arm First Stage Followed by a Two-arm, Parallel Group, Randomized, Placebo (Vehicle) -Controlled Second Stage

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 reflectance confocal microscopy.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Ingenol mebutate	0.05% Ingenol mebutate Gel once daily for 2 consecutive days
DRUG	Placebo Gel	Gel vehicle of PEP005

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-10-10
• Last updated: 2025-03-07
• Results posted: 2015-05-27

Locations

1 site across 1 country: Germany