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The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 43204, 0.018% once daily for 3 days | Experimental |
| |
| LEO 43204, 0.037% once daily for 3 days | Experimental |
| |
| LEO 43204, 0.1% once daily for 3 days | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 43204 | Drug | Treatment of actinic keratosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) | For face/chest, a DLT was defined as one or more of the following three LSRs:
Or two or more of the following five LSRs:
For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs:
Or two or more of the following four LSRs:
| 8 days / From baseline (Day 1) to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 |
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Inclusion Criteria:
Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
Exclusion Criteria:
Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Siegel, MD | Long Island Skin Cancer and Dermatologic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Skin Cancer and Dermatologic Surgery | Smithtown | New York | 11787 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29399263 | Derived | Siegel DM, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Berman B. Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial. J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1. | |
| 29399258 | Derived | Berman B, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Siegel DM. Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial. J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1. |
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 43204 0.018% Face/Chest | Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2. |
| FG001 | LEO 43204 0.037% Scalp | Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2. |
| FG002 | LEO 43204 0.1% Trunk/Extremities | Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population was based on the full analysis set, defined as all participants who assigned to treatment and who met the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 43204 0.018% Face/Chest | Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2. |
| BG001 | LEO 43204 0.037% Scalp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) | For face/chest, a DLT was defined as one or more of the following three LSRs:
Or two or more of the following five LSRs:
For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs:
Or two or more of the following four LSRs:
| Posted | Count of Participants | Participants | 8 days / From baseline (Day 1) to Day 8 |
|
From baseline to Week 8±7 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 | LEO 43204 0.018% Face/Chest | Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Specialist | LEO Pharma A/S | 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 |
|---|---|
| C000612882 | LEO 43204 |
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| Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8. | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 |
| Percentage of Participants With Complete Clearance of AKs | Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | 8 weeks |
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
| BG002 | LEO 43204 0.1% Trunk/Extremities | Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | LEO 43204 0.037% Scalp | Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2. |
| OG002 | LEO 43204 0.1% Trunk/Extremities | Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest). |
|
|
| Secondary | Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | Posted | Mean | 95% Confidence Interval | percentage of reduction | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 |
|
|
|
| Secondary | Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8. | For this efficacy analysis only participants with lesions identified as hypertrophic/hyperkeratotic at baseline were included in the analysis. | Posted | Mean | 95% Confidence Interval | percentage of reduction | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 |
|
|
|
| Secondary | Percentage of Participants With Complete Clearance of AKs | Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
|
|
|
| 1 |
| 63 |
| 35 |
| 63 |
| EG001 | LEO 43204 0.037% Scalp | Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2. | 0 | 63 | 47 | 63 |
| EG002 | LEO 43204 0.1% Trunk/Extremities | Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest). | 0 | 62 | 43 | 62 |
| Application site pruritus | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Application site discomfort | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
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. 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 |
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