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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 |
|---|---|---|---|
| PEP005 (ingenol mebutate) Gel | Active Comparator | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
|
| Vehicle gel | Placebo Comparator | Vehicle gel once daily for 2 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (ingenol mebutate) Gel | Drug | two day treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area | 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area | 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Skin Surgery Medical Group Inc. |
| 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 22 July 2009 (first patient randomized) to 14 October 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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| Vehicle gel |
| Drug |
two day treatment |
|
| San Diego |
| California |
| 92117 |
| United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Karl G. Heine Dermatology | Henderson | Nevada | 89002 | United States |
| Group Health Associates | Cincinnati | Ohio | 45220 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston | Texas | 77056 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| The Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area | Intention to treat population | Posted | Number | participants | 57 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area | Intention to treat population | Posted | Number | participants | 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 | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days | 2 | 100 | 18 | 100 | ||
| EG001 | Vehicle Gel | Vehicle gel once daily for 2 consecutive days | 2 | 103 | 1 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Application site irritation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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 |
|
| Male |
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|
|