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This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP005 (ingenol mebutate) Gel, 0.05% | Experimental |
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| Vehicle Gel | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (ingenol mebutate) Gel, 0.05% | Drug | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels | Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. | 1 day |
| Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels. | Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value. | 1 day |
| Area Under the Blood Conc. Versus Time Curve for Time 0-24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels | Area under the blood conc. versus time curve was calculated for time 0-24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area | Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline | baseline and day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jarratt, MD | Derm Research, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25584134 | Derived | Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29. |
| Label | URL |
|---|---|
| Food and Drug Authority | View source |
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Study Period:
First patient randomized: March 18, 2009 Last patient completed Day 57: May 27, 2009 A single site in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | PEP005 Gel, 0.05% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
| FG001 | Vehicle | Vehicle gel once daily for 2 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle Gel | Drug | Vehicle Gel once daily for 2 consecutive days |
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| Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area |
Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area. |
| Baseline and Day 57 |
| Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study. | Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24. | baseline and Day 2, 3, 8, 15, 29 and 57 |
| Patients With Incidence of Pigmentation and Scarring | Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57 | Baseline, Day 2, 3, 8, 15, 29 and 57 |
| Max Composite Local Skin Response (LSR) Score | Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24. (One vehicle treated patent had a LSR on day 1 only). | Day 3 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PEP005 Gel, 0.05% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
| BG001 | Vehicle | Vehicle gel once daily for 2 consecutive days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Age, Continuous | Mean | Standard Deviation | years |
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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 | Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels | Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. | Posted | Mean | Standard Deviation | ng/mL | 1 day |
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| Primary | Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels. | Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value. | Posted | Number | hours | 1 day |
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| Primary | Area Under the Blood Conc. Versus Time Curve for Time 0-24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels | Area under the blood conc. versus time curve was calculated for time 0-24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. | Posted | Mean | Standard Deviation | ng/mL x h | 1 day |
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| Secondary | Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area | Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline | Posted | Number | participants | baseline and day 57 |
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| Secondary | Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area | Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area. | Posted | Mean | Standard Deviation | change from baseline lesion count (%) | Baseline and Day 57 |
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| Secondary | Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study. | Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24. | Posted | Number | participants | baseline and Day 2, 3, 8, 15, 29 and 57 |
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| Secondary | Patients With Incidence of Pigmentation and Scarring | Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57 | Posted | Number | participants | Baseline, Day 2, 3, 8, 15, 29 and 57 |
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| Secondary | Max Composite Local Skin Response (LSR) Score | Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24. (One vehicle treated patent had a LSR on day 1 only). | Posted | Mean | Standard Deviation | local skin response score | Day 3 |
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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 Gel, 0.05% | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days | 0 | 13 | 3 | 13 | ||
| EG001 | Vehicle | Vehicle gel once daily for 2 consecutive days | 0 | 3 | 2 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA (12.0) |
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| Sinusitis | Infections and infestations | MedDRA (12.0) |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (12.0) |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA (12.0) |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (12.0) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) |
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Evaluator and Principal Investigator agree not to individually publish the result of the study, but rather, to participate in a joint publication of the Study results coordinated by sponsor, who shall have the first righ to publish. If such joint publication is not submitted for publication within 1 year of study completion at all sites Evaluator and Principal Investigator have the right to individually produce and submit a proposed publication, subject to the prior review of sponsor.
| 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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