Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 43204 | 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) | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area. | At Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Clearance of AKs | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. | At Week 8 |
| Percentage of Participants With Partial Clearance of AKs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel M Siegel, MD | Long Island Skin Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Skin Cancer & Dermatologic Surgery | Smithtown | New York | 11787 | United States |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
373 participants were enrolled, 57 were screening failures, and 316 participants were randomized. Only 313 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.
Not provided
| 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 |
|
| ||||||||||||||||||||||||
| 12-month Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LEO 43204 0.037% Gel | Treatment once daily for 3 days with LEO 43204 0.037% gel |
| BG001 | Vehicle Gel | Treatment once daily for 3 days with 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) | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area. | 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.
Not provided
| 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 for 3 days with LEO 43204 0.037% gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periorbital oedema | Eye disorders | 18.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Specialist | LEO Pharma A/S | disclosure@leo-pharma.com |
Not provided
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. |
| 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. The table presents adjusted mean percent reduction at Week 8 from baseline. | At Week 8 |
| Lost to Follow-up |
|
| Other |
|
| 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 of AKs | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
|
|
|
| Secondary | Percentage of Participants With Partial Clearance of AKs | Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. | 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. The table presents adjusted mean percent reduction at Week 8 from baseline. | Posted | Mean | 95% Confidence Interval | percentage of reduction | At Week 8 |
|
|
|
|
| 4 |
| 209 |
| 153 |
| 209 |
| EG001 | Vehicle Gel | Treatment once daily for 3 days with vehicle gel | 2 | 104 | 9 | 104 |
| EG002 | LEO 43204 0.037% Gel - Extended Follow-up | Treatment once daily for 3 days with LEO 43204 0.037% gel | 1 | 204 | 18 | 204 |
| EG003 | Vehicle Gel - Extended Follow-up | Treatment once daily for 3 days with vehicle gel | 0 | 86 | 12 | 86 |
| Pericarditis | Cardiac disorders | 18.1 | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | 18.1 | Non-systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Neoplasm of appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Non-systematic Assessment |
|
| Application site discomfort | General disorders | 18.1 | Non-systematic Assessment |
|
| Application site injury | General disorders | 18.1 | Non-systematic Assessment |
|
| Application site pain | General disorders | 18.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | 18.1 | Non-systematic Assessment |
|
| Application site scar | General disorders | 18.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | 18.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Post inflammatory pigmentation change | Skin and subcutaneous tissue disorders | 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 |