NCT01214564

Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Conditions

• Seborrheic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005 (ingenol mebutate) Gel	0.05%

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-10-05
• Last updated: 2011-01-25

Locations

2 sites across 1 country: Australia