Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP005 gel | Experimental | PEP005 gel, 0.015% applied once daily for three consecutive days |
|
| Vehicle gel | Placebo Comparator | Vehicle gel applied once daily for three consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 Gel | Drug | 0.015%, three day treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | 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 (AK) | Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area | baseline and 57 days |
Not provided
Inclusion Criteria:
Patient is male or female and at least 18 years of age
Female patients must be of either:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eugene Bauer, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | United States | ||
| Dermatology Specialists 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 |
Not provided
Not provided
Study PEP005-016 was conducted at 21 study centers in the United States and Australia. A total of 269 patients were randomized. Patient screening was started on 01 June 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 10 September 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PEP005 (Ingenol Mebutate) Gel, 0.015% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days |
| FG001 | Vehicle | Vehicle gel once daily for 3 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle gel | Drug | Vehicle gel, three day treatment |
|
|
| Oceanside |
| California |
| 92056 |
| United States |
| Skin Surgery Medical Group Inc. | San Diego | California | 92117 | United States |
| Conant Medical Group | San Francisco | California | 94114 | United States |
| University of Miami, Skin Research Camp | Miami | Florida | 33136 | United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | United States |
| Medaphase Inc | Newnan | Georgia | 30263 | United States |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | United States |
| Dawes Fretein Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Pedia Research LLC | Owensboro | Kentucky | 42301 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | United States |
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia |
| St George Dematology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| Therapeutic Goods Administration | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEP005 (Ingenol Mebutate) Gel, 0.015% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days |
| BG001 | Vehicle | 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 |
| ||||||||||||||||||
| 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 | Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | 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 (AK) | Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area | Intention to treat population | Posted | Number | participants | baseline and 57 days |
|
|
57 days
For the safety population, the total sample size was 132 patients who received PEP005 Gel (2 patients never received study medication and one patient actually received vehicle gel) and 135 patients who received vehicle gel.
Not provided
| 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 | 2 | 132 | 39 | 132 | ||
| EG001 | Vehicle | Vehicle gel once daily for 3 consecutive days | 2 | 135 | 3 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Campylobacter infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment | Severe, Not related, Recovered |
|
| Meniscus Lesion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment | Lateral meniscus tear due to work injury, Severe, Not related, Recovered |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| 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 |
|
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 | tosdk@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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Australia |
|
|
|