Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
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ClinicalTrials.gov Identifier: NCT00107965 |
Recruitment Status :
Completed
First Posted : April 12, 2005
Last Update Posted : March 25, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Actinic Keratosis | Drug: PEP005 | Phase 2 |
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 |
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) |
- 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 ]
- To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses [ Time Frame: 85 days ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107965
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 |
Principal Investigator: | Greg Siller |
Responsible Party: | Janelle Katsamas, Peplin |
ClinicalTrials.gov Identifier: | NCT00107965 |
Other Study ID Numbers: |
PEP005-001 2005/145 |
First Posted: | April 12, 2005 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | March 2015 |
Actinic Keratosis Solar Keratosis AK Sun spots |
PEP005 Topical Dermatology |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms |