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The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | PEP005 (ingenol mebutate) Gel |
|
| 2 | Placebo Comparator | Vehicle gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (ingenol mebutate) Gel | Drug | two day treatment |
| |
| Vehicle gel |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Complete Clearance of Actinic Keratosis (AKs) | Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. | 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Partial Clearance of Actinic Keratosis (AKs) | Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area. | baseline and 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omni Dermatology Research | Mesa | Arizona | 85206 | United States | ||
| Colorado Medical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22417254 | Derived | Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170. |
| Label | URL |
|---|---|
| Food and Drug Authority | View source |
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The study period was 05 September 2008 (first patient randomized) to 23 February 2009 (last patient completed Day 57)
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| ID | Title | Description |
|---|---|---|
| FG000 | PEP005 (Ingenol Mebutate) Gel | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
| FG001 | Vehicle Gel | Vehicle gel once daily for 2 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
two day treatment |
|
| Denver |
| Colorado |
| 80210 |
| United States |
| Advanced Dermatology and Cosmetic Research | Kissimmee | Florida | 34741 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Advanced Dermatology & Cosmetic Surgery | Ormond Beach | Florida | 32174 | United States |
| Medaphase Inc | Newnan | Georgia | 30263 | United States |
| Gwinnett Clinical Research Centre | Snellville | Georgia | 30078-3250 | United States |
| Dermatology Center of Indiana/Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | United States |
| Karen S. Harkaway, MD. LLC | South Delran | New Jersey | 08075 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44121 | United States |
| Oregon Medical Research | Portland | Oregon | 97223 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239-4501 | United States |
| Dermatology East | Germantown | Tennessee | 38138 | United States |
| Rivergate Dermatology and Skin Care Center | Goodlettsville | Tennessee | 37072 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Burswood Dermatology | Victoria Park | Western Australia | 6100 | Australia |
| Therapeutic Goods Administration | View source |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEP005 (Ingenol Mebutate) Gel | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
| BG001 | Vehicle Gel | Vehicle gel once daily for 2 consecutive days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Complete Clearance of Actinic Keratosis (AKs) | Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. | Intention to treat population | Posted | Number | Participants | 57 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Partial Clearance of Actinic Keratosis (AKs) | Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area. | Intention to treat population | Posted | Number | participants | baseline and 57 days |
|
|
57 days
One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEP005 (Ingenol Mebutate) Gel | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days | 1 | 125 | 0 | 125 | ||
| EG001 | Vehicle Gel | Vehicle gel once daily for 2 consecutive days | 3 | 129 | 0 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lymphoma (neck) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
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After the Study is completed, Institution shall have the right to publish their own data resulting from the Study upon the earlier of (a) publication of a multi-center publication coordinated by Sponsor or (b) the date of submission of the data resulting from the Study by Sponsor to the FDA. Institution shall furnish Sponsor with a copy of any proposed publication or release at least 90 days in advance of the proposed submission or presentation date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Torsten Skov | LEO Pharma | +4520736294 | torsten.skov@leo-pharma.com |
| 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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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Australia |
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