Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

Study Description

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Brief Summary:

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Condition or disease	Intervention/treatment	Phase
Actinic Keratosis	Drug: PEP005	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses
Study Start Date :	March 2005
Actual Primary Completion Date :	September 2005
Actual Study Completion Date :	September 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application)
Experimental: 2	Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application)
Experimental: 3	Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application)
Placebo Comparator: 4	Drug: PEP005; Vehicle Gel (Day 1,2 application)
Experimental: 5	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application)
Experimental: 6	Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application)
Experimental: 7	Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application)
Placebo Comparator: 8	Drug: PEP005; Vehicle Gel (Day 1,8 application)

Outcome Measures

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Primary Outcome Measures :

1. To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp [ Time Frame: 85 days ]

Secondary Outcome Measures :

1. To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses [ Time Frame: 85 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or female patients
• At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

• A cosmetic or therapeutic procedure:

  • within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study

• Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

  • of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
• Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
• Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
• Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
• Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
• Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
• Females of childbearing potential

Contacts and Locations

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Locations

Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Queensland
Siller Medical
Brisbane, Queensland, Australia, 4000
Australia, Victoria
Skin and Cancer Foundation
Melbourne, Victoria, Australia, 3052
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Private Dermaology Clinic
Fremantle, Western Australia, Australia, 6160

Sponsors and Collaborators

Peplin

Investigators

Principal Investigator:	Greg Siller

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at LEO Pharma 

Responsible Party:	Janelle Katsamas, Peplin
ClinicalTrials.gov Identifier:	NCT00107965 History of Changes
Other Study ID Numbers:	PEP005-001; 2005/145
First Posted:	April 12, 2005
Last Update Posted:	March 25, 2015
Last Verified:	March 2015

Keywords provided by Peplin:

Actinic Keratosis; Solar Keratosis; AK; Sun spots	PEP005; Topical; Dermatology

Additional relevant MeSH terms:

Keratosis; Keratosis, Actinic; Skin Diseases; Precancerous Conditions; Neoplasms