Status:
COMPLETED
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Eligibility Criteria
Inclusion
- Male or female patients
- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00107965
Start Date
March 1 2005
End Date
September 1 2005
Last Update
March 25 2015
Active Locations (6)
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1
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
2
Siller Medical
Brisbane, Queensland, Australia, 4000
3
Skin and Cancer Foundation
Melbourne, Victoria, Australia, 3052
4
Monash Medical Centre
Melbourne, Victoria, Australia, 3168