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Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

Phase 2
Completed
Conditions
Photo-damage
Interventions
Drug: PEP005 (ingenol mebutate) Gel
Registration Number
NCT01214577
Lead Sponsor
Peplin
Brief Summary

This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.

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, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.Day 43
Secondary Outcome Measures
NameTimeMethod
To determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.Day 43

Trial Locations

Locations (2)

The Skin Centre

🇦🇺

Benowa, Queensland, Australia

Specialist Connect

🇦🇺

Woolloongabba, Queensland, Australia

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