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This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP005 (Ingenol Mebutate) gel | Experimental |
| |
| Vehicle gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (Ingenol Mebutate) gel, 0.015% | Drug | once daily for 3 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance of Actinic Keratoses (AK) Lesions | Complete clearance of the treatment field | baseline and 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Clearance of Actinic Keratoses (AK) | Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area | baseline and 57 days |
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Inclusion Criteria:
Patient is male or female and at least 18 years of age
Female patients must be of either:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Center for Dermatology |
| 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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Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEP005 (Ingenol Mebutate) Gel, 0.015% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days |
| FG001 | Vehicle Gel | Vehicle gel once daily for 3 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Gel | Drug | once daily for 3 consecutive days |
|
| Fremont |
| California |
| 94538 |
| United States |
| North Florida Dermatology Associates, PA | Jacksonville | Florida | 32204 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Laser Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | United States |
| Deaconess Clinic, Inc | Evansville | Indiana | 47713 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Skin Specialists, PC | Omaha | Nebraska | United States |
| Karl G. Heine Dermatology | Henderson | Nevada | 89002 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029-6574 | United States |
| Dermatology Associates of Rochester, PC | Rochester | New York | 14623 | United States |
| Dermatology, Laser Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston | Texas | 77056 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| The Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| South East Dermatology, Belmont Specialist Centre | Carina Heights | Queensland | 4152 | 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, 0.015% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days |
| BG001 | Vehicle Gel | Vehicle gel once daily for 3 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Complete Clearance of Actinic Keratoses (AK) Lesions | Complete clearance of the treatment field | Intention to treat population | Posted | Number | participants | baseline and 57 days |
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| Secondary | Partial Clearance of Actinic Keratoses (AK) | Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area | Intention to treat population | Posted | Number | participants | baseline and 57 days |
|
|
57 days
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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, 0.015% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days | 1 | 142 | 20 | 142 | ||
| EG001 | Vehicle Gel | Vehicle gel once daily for 3 consecutive days | 0 | 136 | 1 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Arthroplasty (Hip Replacement) | Surgical and medical procedures | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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For US sites: The institution and investigator agree not to publish the results of this study without prior written consent of the Sponsor. As used herein, the term "publish" shall include oral presentations,written abstracts, written manuscripts, etc.
| 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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| >=65 years |
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| Male |
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| Australia |
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