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The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 43204 gel | Experimental | Treatment once daily for 3 days |
|
| Vehicle gel | Placebo Comparator | Treatment once daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 43204 gel | Drug |
| ||
| Vehicle gel |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) | Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance. | At Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Clearance (Multiple Imputation) | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance. | At Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bukhalo, MD | Altman Dermatology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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A total of 437 participants were enrolled across 4 countries: United States, United Kingdom, France, and Spain. 130 were screening failures, and 307 participants were randomized to 1 of the 2 treatment groups
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 43204 0.018% Gel | Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest. |
| FG001 | Vehicle Gel | Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-day Treatment and 8-week Follow-up |
|
| ||||||||||||||||||||||||
| 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 43204 0.018% Gel | Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel |
| BG001 | Vehicle Gel | Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel |
| 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 | Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) | Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review.
For further details on the adjudication outcomes, see link to the full report in section "More information"
Adverse events are reported with a >=2% frequency threshold for the active treatment group.
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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% Gel - Treatment Period Including Follow-up | Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periorbital oedema | Eye disorders | MedDRA (18.1) | 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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|
| Percentage of Participants With Partial Clearance (Multiple Imputation) |
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance. |
| At Week 4 |
| Percent Reduction in AK Count in the Treatment Area Compared to Baseline | The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline. | At Week 8 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants With Partial Clearance (Multiple Imputation) | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
|
|
|
| Secondary | Percentage of Participants With Partial Clearance (Multiple Imputation) | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 4 |
|
|
|
|
| Secondary | Percent Reduction in AK Count in the Treatment Area Compared to Baseline | The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline. | Posted | Mean | 95% Confidence Interval | percentage of reduction | At Week 8 |
|
|
|
|
| 2 |
| 205 |
| 134 |
| 205 |
| EG001 | Vehicle Gel - Treatment Period Including Follow-up | Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel | 0 | 100 | 3 | 100 |
| EG002 | LEO 43204 0.018% Gel - Extended Follow-up | Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel | 0 | 199 | 23 | 199 |
| EG003 | Vehicle Gel - Extended Follow-up | Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel | 0 | 84 | 3 | 84 |
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site discomfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Scar | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (18.1) | 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 |