MedPath

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

Phase 2
Completed
Conditions
Seborrheic Keratosis
Interventions
Drug: PEP005 (ingenol mebutate) Gel
Registration Number
NCT01214564
Lead Sponsor
Peplin
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1PEP005 (ingenol mebutate) GelUp to three days of treatment
Primary Outcome Measures
NameTimeMethod
To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.Day 43
Secondary Outcome Measures
NameTimeMethod
To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.Day 43

Trial Locations

Locations (2)

Specialist Connect

🇦🇺

Woolloongabba, Queensland, Australia

Southderm Pty Ltd

🇦🇺

Kogarah, New South Wales, Australia

© Copyright 2025. All Rights Reserved by MedPath