Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
NCT ID: NCT00107965
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2005-03-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PEP005
0.0025% PEP005 Topical Gel (Day 1,2 application)
2
PEP005
0.01% PEP005 Topical Gel (Day 1,2 application)
3
PEP005
0.05% PEP005 Topical Gel (Day 1,2 application)
4
PEP005
Vehicle Gel (Day 1,2 application)
5
PEP005
0.0025% PEP005 Topical Gel (Day 1,8 application)
6
PEP005
0.01% PEP005 Topical Gel (Day 1,8 application)
7
PEP005
0.05% PEP005 Topical Gel (Day 1,8 application)
8
PEP005
Vehicle Gel (Day 1,8 application)
Interventions
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PEP005
0.0025% PEP005 Topical Gel (Day 1,2 application)
PEP005
0.01% PEP005 Topical Gel (Day 1,2 application)
PEP005
0.05% PEP005 Topical Gel (Day 1,2 application)
PEP005
Vehicle Gel (Day 1,2 application)
PEP005
0.0025% PEP005 Topical Gel (Day 1,8 application)
PEP005
0.01% PEP005 Topical Gel (Day 1,8 application)
PEP005
0.05% PEP005 Topical Gel (Day 1,8 application)
PEP005
Vehicle Gel (Day 1,8 application)
Eligibility Criteria
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Inclusion Criteria
* At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Peplin
Principal Investigators
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Greg Siller
Role: PRINCIPAL_INVESTIGATOR
Locations
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Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Siller Medical
Brisbane, Queensland, Australia
Skin and Cancer Foundation
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Private Dermaology Clinic
Fremantle, Western Australia, Australia
Countries
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Other Identifiers
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2005/145
Identifier Type: -
Identifier Source: secondary_id
PEP005-001
Identifier Type: -
Identifier Source: org_study_id
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