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

Peplin2 sites in 1 country24 target enrollmentOctober 2010

ConditionsSeborrheic Keratosis

InterventionsPEP005 (ingenol mebutate) Gel

DrugsPEP005 (ingenol mebutate) Gel

Overview

Phase: Phase 2
Intervention: PEP005 (ingenol mebutate) Gel
Conditions: Seborrheic Keratosis
Sponsor: Peplin
Enrollment: 24
Locations: 2
Primary Endpoint: To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peplin

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Up to three days of treatment

Intervention: PEP005 (ingenol mebutate) Gel

Outcomes

Primary Outcomes

To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Time Frame: Day 43

Secondary Outcomes

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)