Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
This study has been completed.
Sponsor:
Peplin
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00107965
First received: April 11, 2005
Last updated: March 24, 2015
Last verified: March 2015
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Purpose
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
| Condition | Intervention | Phase |
|---|---|---|
|
Actinic Keratosis |
Drug: PEP005 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Peplin:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses [ Time Frame: 85 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107965
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107965
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
Additional Information:
| Responsible Party: | Janelle Katsamas, Peplin |
| ClinicalTrials.gov Identifier: | NCT00107965 History of Changes |
| Other Study ID Numbers: | PEP005-001 2005/145 |
| Study First Received: | April 11, 2005 |
| Last Updated: | March 24, 2015 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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 |
ClinicalTrials.gov processed this record on September 30, 2016