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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 the balding scalp 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 |
|---|---|---|---|---|
| LEO43204 gel | Drug |
|
| |
| Vehicle gel |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8. | At Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Clearance | The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. 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 |
|---|---|---|
| Rolf-Markus Szeimies, Prof. Dr.med | Klinik für Dermatologie & Allergologie Klinikum Vest GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Dermatologie & Allergologie Klinikum Vest GmbH | Recklinghausen | 45657 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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391 participants were enrolled, 80 were screening failures, and 311 participants were randomized. Only 310 of the randomized participants were treated with investigational medicinal product (IMP), the number of participants treated is reflected as the number of participants started in the first period.
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 43204 0.037% Gel | Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp. |
| FG001 | Vehicle Gel | Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-day Treatment and 8-week Follow-up |
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| ||||||||||||||||||||||||
| 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 43204 0.037% Gel | Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp. |
| BG001 | Vehicle Gel | Treatment once daily with vehicle gel for 3 consecutive days applied on the 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 | Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8. | 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 0.037% Gel | Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General 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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| Drug |
|
| At Week 8 |
| Percentage of Participants With Partial Clearance | The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. 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. | 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 |
| Other |
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| 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 |
|
|
|
|
| Secondary | Percentage of Participants With Partial Clearance | The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
|
|
|
| Secondary | Percentage of Participants With Partial Clearance | The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. 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. | 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 change | At Week 8 |
|
|
|
|
| 3 |
| 210 |
| 146 |
| 210 |
| EG001 | Vehicle Gel | Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp. | 3 | 100 | 12 | 100 |
| EG002 | LEO 43204 0.037% Gel - Extended Follow-up | Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp. | 0 | 208 | 5 | 208 |
| EG003 | Vehicle Gel - Extended Follow-up | Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp. | 0 | 92 | 1 | 92 |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | 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 |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |