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This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP005 Gel 0.05% | Active Comparator | active ingredient of PEP005: Ingenol mebutate |
|
| Placebo Gel | Placebo Comparator | Vehicle of PEP005 Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol mebutate | Drug | 0.05% Ingenol mebutate Gel once daily for 2 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 2 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 2 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eggert Stockfleth, Prof Dr med | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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Start date: 27-Sep-2011 (FSFV - first subject first visit) Completion date: 22-May-2012 (LSLV - last subject last visit)
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| ID | Title | Description |
|---|---|---|
| FG000 | Ingenol Mebutate Gel (PEP005 Gel) | Ingenol mebutate gel (PEP005 gel) Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area |
| FG001 | Vehicle | Vehicle of PEP005 Gel Vehicle gel once daily on two consecutive days to an 25cm2 area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ingenol Mebutate Gel (PEP005 Gel) | Ingenol mebutate gel (PEP005 gel) Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area |
| BG001 | Vehicle | Vehicle of PEP005 Gel Vehicle gel once daily on two consecutive days to an 25cm2 area |
| 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 |
| 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 | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage change | Baseline to Day 2 |
|
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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 | Ingenol Mebutate Gel (PEP005 Gel) | Ingenol mebutate gel (PEP005 gel) Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive crisis | Vascular disorders | MedDRA 14.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | ctr.disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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| Placebo Gel | Drug | Gel vehicle of PEP005 |
|
| Baseline to Day 2 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | Baseline to Day 3 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 3 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 3 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 8 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 8 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 8 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 57 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 57 |
| Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | Baseline to Day 57 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | Baseline to Day 2 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | Baseline to Day 2 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | Baseline to Day 2 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | Baseline to Day 3 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | Baseline to Day 3 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | Baseline to Day 3 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | Baseline to Day 8 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | Baseline to Day 8 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | Baseline to Day 8 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | Baseline to Day 57 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | Baseline to Day 57 |
| Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin | Baseline to Day 57 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Ingenol Mebutate Gel (PEP005 Gel) | Ingenol mebutate gel (PEP005 gel) Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area |
| OG001 | Vehicle | Vehicle of PEP005 Gel Vehicle gel once daily on two consecutive days to an 25cm2 area |
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 2 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 2 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin. The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
|
| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
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| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
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| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
|
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| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
|
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| Primary | Change in Degree of Infiltration | Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. | As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 2 |
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 2 |
|
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 2 |
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 3 |
|
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| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
|
|
| Primary | Change in Degree of Necrosis | Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin | As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle. | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 57 |
|
|
|
| 1 |
| 16 |
| 16 |
| 16 |
| EG001 | Vehicle | Vehicle of PEP005 Gel Vehicle gel once daily on two consecutive days to an 25cm2 area | 0 | 8 | 1 | 8 |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 14.1 |
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| Hyperthermia | General disorders | MedDRA 14.1 |
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| Pain | General disorders | MedDRA 14.1 |
|
| Swelling | General disorders | MedDRA 14.1 |
|
| Postoperative wound | Infections and infestations | MedDRA 14.1 |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
|
| Burning sensation | Nervous system disorders | MedDRA 14.1 |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Skin oedema | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Hypertension | Vascular disorders | MedDRA 14.1 |
|
| Hypertensive crisis | Vascular disorders | MedDRA 14.1 |
|
LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| D017437 |
| Skin and Connective Tissue Diseases |