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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000228-85 | EudraCT Number |
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Study halted prematurely and will not resume; participants are no longer being examined.
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One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial.
In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol disoxate gel 0.018% | Experimental |
| |
| Ingenol disoxate gel 0.037% | Experimental |
| |
| Vehicle gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ingenol disoxate gel 0.018% | Drug | Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area | Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis | From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area | Time to first squamous cell carcinoma (SCC) or other skin neoplasia in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis |
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Inclusion Criteria:
Exclusion Criteria:
For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Center for Dermatology Clinical Research, Inc. |
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1234 participants were randomised and applied investigational medicinal product (IMP) in the trials LP0084-1193, -1194, -1195, -1196 (main trials, Period 1).
A total of 563 participants from the main trials continued and were enrolled into this extension follow-up trial (LP0084-1369, Period 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ingenol Disoxate Gel 0.018% | ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses (AKs) on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
| FG001 | Ingenol Disoxate Gel 0.037% |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Main Trials (LP0084-119x) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2017 | Jan 16, 2019 |
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|
| ingenol disoxate gel 0.037% | Drug | Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
|
|
| Vehicle gel | Other | Vehicle to ingenol disoxate gel with no active ingredient |
|
| From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months |
| Fremont |
| California |
| 94538 |
| United States |
| Dermatology Specialists, Inc | Murrieta | California | 92562 | United States |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | United States |
| Contour Dermatology & Cosmetic Surgery Center | Rancho Mirage | California | 92270 | United States |
| Skin Surgery Medical Group, Inc. | San Diego | California | 92117 | United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| University Clinical Trials, Inc. | San Diego | California | 92123 | United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80210 | United States |
| AboutSkin Dermatology and DermSurgery, PC | Greenwood Village | Colorado | 80111 | United States |
| Dermatology and Dermatologic Surgery | Danbury | Connecticut | 06810 | United States |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Visions Clincal Research | West Palm Beach | Florida | 33406 | United States |
| MedaPhase | Newnan | Georgia | 30263 | United States |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States |
| Laser & Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | United States |
| Research Institute of Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| DermAssociates, PC | Rockville | Maryland | 20850 | United States |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | United States |
| Clarkston Skin Research | Clarkston | Michigan | 48346 | United States |
| Clinical Studies Group | Henderson | Nevada | 89074 | United States |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Center for Clinical Studies | Houston | Texas | 77065 | United States |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Katy | Texas | 77494 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Investigational Site | Vancouver | British Columbia | V6E 4M3 | Canada |
| Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Investigational Site | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Investigational Site | Ajax | Ontario | L1S 7K8 | Canada |
| Investigational Site | Barrie | Ontario | L4M 7G1 | Canada |
| Investigational Site | London | Ontario | N6A 3H7 | Canada |
| Investigational Site | Mississauga | Ontario | L5H 1G9 | Canada |
| Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Investigational Site | Drummondville | Quebec | J2B 5L4 | Canada |
| Investigational Site | Chambray-lès-Tours | 37170 | France |
| Investigational Site | Nice | 06202 Cedex 3 | France |
| Investigational Site | Saint-Etienne | 42055 Cedex 2 | France |
| Investigational Site | Berlin | 10117 | Germany |
| Investigational Site | Dresden | 1097 | Germany |
| Investigational Site | Frankfurt am Main | 60590 | Germany |
| Investigational Site | Hamburg | 22391 | Germany |
| Investigational Site | Hanover | 30159 | Germany |
| Investigational Site | Münster | 48149 | Germany |
| Investigational Site | Recklinghausen | 45657 | Germany |
| Investigational Site | Schweinfurt | 97421 | Germany |
| Investigational Site | Badalona | Barcelona | 08916 | Spain |
| Investigational Site | Pamplona | Navarre | 31008 | Spain |
| Investigational Site | Valencia | 46026 | Spain |
| Investigational Site | Dundee | Angus | DD1 9SY | United Kingdom |
| Investigational Site | Airdrie | Lanarkshire | ML6 OJS | United Kingdom |
| Investigational Site | Middlesbrough | North Yorkshire | TS4 3BW | United Kingdom |
| Investigational Site | Redhill | Surrey | RH1 5RH | United Kingdom |
ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
| FG002 | Vehicle Gel | Vehicle gel to Ingenol disoxate gel with no active ingredient |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| LP0084-1369 |
|
|
Of the 1234 participants who were randomised and applied IMP in the Main Trials (Period1) a total of 563 participants continued into this extension follow-up trial. The endpoints in this trial are time to event endpoints, starting at randomisation in the Main Trials, and therefore the full analysis set consists of 1234 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Ingenol Disoxate Gel 0.018% | ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
| BG001 | Ingenol Disoxate Gel 0.037% | ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
| BG002 | Vehicle Gel | Vehicle gel of ingenol disoxate gel |
| BG003 | 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 |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Fitzpatrick skin type | Fitzpatrick scale description: Type I - always burns, never tans (palest; freckles). Type II - usually burns, tans minimally Type III - sometimes mild burn, tans uniformly Type IV - burns minimally, always tans well (moderate brown) Type V - very rarely burns, tans very easily (dark brown) Type VI - never burns (deeply pigmented dark brown to darkest brown) | Count of Participants | 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 | Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area | Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis | Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials | Posted | Number | 95% Confidence Interval | SCC events per 100 patient years | From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area | Time to first squamous cell carcinoma (SCC) or other skin neoplasia in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis | Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials | Posted | Number | 95% Confidence Interval | SCC events per 100 patient years | From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months |
|
From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued
Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error.
Safety information is reported based on the actual treatment
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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 Disoxate Gel 0.018% | ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. | 1 | 191 | 0 | 191 | 16 | 191 |
| EG001 | Ingenol Disoxate Gel 0.037% | ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. | 0 | 211 | 1 | 211 | 6 | 211 |
| EG002 | Vehicle Gel | Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. | 2 | 161 | 0 | 161 | 10 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site scar | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Application site papules | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Inflammation of wound | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
Early termination leading to small numbers of subjects analyzed
LEO Pharma acknowledges the investigator right to publish the entire results of the study, irrespective of outcome. LEO Pharma retains the right to have any publication submitted to LEO Pharma for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO Pharma.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | LEO Pharma | +45 4494 5888 | disclosure@leo-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2018 | Jan 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C000612882 | LEO 43204 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Spain |
|
| Type II |
|
| Type III |
|
| Type IV |
|
| Type V |
|
Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp. |
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