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Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cohort 1 One 25 cm2 treatment area; on one arm |
|
| 2 | Experimental | Cohort 2 One 50cm2 contiguous treatment area; on one arm |
|
| 3 | Experimental | Cohort 3 Two 25cm2 treatment areas; one on each arm |
|
| 4 | Experimental | Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm |
|
| 5 | Experimental | Cohort 5 One 75cm2 contiguous treatment area; on one arm |
|
| 6 | Experimental | Cohort 6 Two 50cm2 contiguous treatment area; one on each arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 Topical gel | Drug | 0.05%, two day dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (incidence of AEs, SAEs and skin responses) | Screening to End of Study (Day 57) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Schmieder, DO | Park Avenue Dermatology | Principal Investigator |
| Stephen Shumack, MD | St George Dermatology and Skin and Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Tucson | Arizona | 85710 | United States | ||
| Skin Surgery Medical Group Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25584134 | Derived | Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29. |
| Label | URL |
|---|---|
| Food and Drug Administration | View source |
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| 7 | Experimental | Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm |
|
| 8 | Experimental | Cohort 8 One 100cm2 contiguous treatment area; on one arm |
|
| San Diego |
| California |
| 92117 |
| United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Advanced Dermatology and Cosmetic Surgery | Ormond Beach | Florida | 32174 | United States |
| Radiant Research Inc. | Pinellas Park | Florida | 33781 | United States |
| Medaphase Inc | Newnan | Georgia | 30263 | United States |
| Karen S. Harkaway, MD LLC | Riverside Park | New Jersey | 08075 | United States |
| J&S Studies | College Station | Texas | 77845 | United States |
| St George Dematology and Skin and Cancer Centre | Kogarah, Sydney | New South Wales | 2217 | Australia |
| South East Dermatology, Belmont Specialist Centre | Carina Heights, Brisbane | Queensland | 4152 | Australia |
| Skin and Cancer Foundation | Carlton, Melbourne | Victoria | 3053 | Australia |
| St John of God Dermatology | Subiaco, Perth | Western Australia | 6008 | Australia |
| Burswood Dermatology | Victoria Park, Perth | Western Australia | 6100 | Australia |
| Therapeutic Goods Administration | View source |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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