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 face or chest 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 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 |
|---|---|---|
| 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, Week 4, and Week 8. Complete clearance was defined as no clinically visible AKs 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) | The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| C. William Hanke, MD | Laser & Skin Surgery Center of Indiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | 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
A total of 383 participants were enrolled across 5 countries: United States, Canada, Germany, Spain, and Italy. 74 were screening failures, and 309 participants were randomized to 1 of the 2 treatment groups.
Not provided
| 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 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LEO 43204 0.018% Gel | Treatment once daily for 3 days with LEO 43204 0.018% 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 | 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, Week 4, and Week 8. Complete clearance was defined as no clinically visible AKs 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"
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 0.018% Gel | Treatment once daily for 3 days LEO 43204 0.018% gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment | The event was classified as serious because the participant was hospitalized. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (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
|
| At Week 8 |
| Percentage of Participants With Partial Clearance (Multiple Imputation) | The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 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 |
| 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 |
|
| 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) | The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
|
|
|
| Secondary | Percentage of Participants With Partial Clearance (Multiple Imputation) | The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 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. | 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 |
|
|
|
|
| 0 |
| 202 |
| 136 |
| 202 |
| EG001 | Vehicle Gel | Treatment once daily for 3 days Vehicle gel | 0 | 104 | 32 | 104 |
| EG002 | LEO 43204 0.018% Gel - Extended Follow-up | Treatment once daily for 3 days LEO 43204 0.018% gel | 1 | 201 | 35 | 201 |
| EG003 | Vehicle Gel - Extended Follow-up | Treatment once daily for 3 days Vehicle gel | 0 | 98 | 14 | 98 |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site discomfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site warmth | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site dryness | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site haematoma | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site laceration | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site nodule | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hangover | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pyrexia | General 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 |
|
| Lacrimation increased | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eczema eyelids | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eyelid pain | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Sunburn | 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 |
|
| Bowen's disease | 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 |
|
| Anosmia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Post inflammatory pigmentation change | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypertrophic scar | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site scar | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site discolouration | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Application site macule | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Scar | Injury, poisoning and procedural complications | 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 |