Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
This study has been completed.
Sponsor:
Peplin
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00659893
First received: April 15, 2008
Last updated: November 4, 2008
Last verified: November 2008
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Purpose
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
| Condition | Intervention | Phase |
|---|---|---|
|
Actinic Keratosis |
Drug: PEP005 Topical gel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Open Label, Dose-Area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s) |
Resource links provided by NLM:
Further study details as provided by Peplin:
Primary Outcome Measures:
- Safety and tolerability (incidence of AEs, SAEs and skin responses) [ Time Frame: Screening to End of Study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 64 |
| Study Start Date: | April 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cohort 1 One 25 cm2 treatment area; on one arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 2
Cohort 2 One 50cm2 contiguous treatment area; on one arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 3
Cohort 3 Two 25cm2 treatment areas; one on each arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 4
Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 5
Cohort 5 One 75cm2 contiguous treatment area; on one arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 6
Cohort 6 Two 50cm2 contiguous treatment area; one on each arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 7
Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
|
Experimental: 8
Cohort 8 One 100cm2 contiguous treatment area; on one arm
|
Drug: PEP005 Topical gel
0.05%, two day dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be male and at least 18 years of age.
- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
Exclusion Criteria:
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659893
Locations
| United States, Arizona | |
| Radiant Research | |
| Tucson, Arizona, United States, 85710 | |
| United States, California | |
| Skin Surgery Medical Group Inc. | |
| San Diego, California, United States, 92117 | |
| United States, Florida | |
| Park Avenue Dermatology | |
| Orange Park, Florida, United States, 32073 | |
| Advanced Dermatology and Cosmetic Surgery | |
| Ormond Beach, Florida, United States, 32174 | |
| Radiant Research Inc. | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Georgia | |
| Medaphase Inc | |
| Newnan, Georgia, United States, 30263 | |
| United States, New Jersey | |
| Karen S. Harkaway, MD LLC | |
| Delran, New Jersey, United States, 08075 | |
| United States, Texas | |
| J&S Studies | |
| College Station, Texas, United States, 77845 | |
| Australia, New South Wales | |
| St George Dematology and Skin and Cancer Centre | |
| Kogarah, Sydney, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
| South East Dermatology, Belmont Specialist Centre | |
| Carina Heights, Brisbane, Queensland, Australia, 4152 | |
| Australia, Victoria | |
| Skin and Cancer Foundation | |
| Carlton, Melbourne, Victoria, Australia, 3053 | |
| Australia, Western Australia | |
| St John of God Dermatology | |
| Subiaco, Perth, Western Australia, Australia, 6008 | |
| Burswood Dermatology | |
| Victoria Park, Perth, Western Australia, Australia, 6100 | |
Sponsors and Collaborators
Peplin
Investigators
| Principal Investigator: | George Schmieder, DO | |
| Principal Investigator: | Stephen Shumack, MD |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janelle Katsamas, Peplin Operations Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00659893 History of Changes |
| Other Study ID Numbers: | PEP005-022 |
| Study First Received: | April 15, 2008 |
| Last Updated: | November 4, 2008 |
| Health Authority: | United States: Food and Drug Administration Australia: Therapeutic Goods Administration |
Keywords provided by Peplin:
|
Peplin PEP005 Actinic Keratosis |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013