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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2009-013792-22 | Registry Identifier | European Clinical Trials Database |
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This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 29102 0.03 mg/g cream | Experimental |
| |
| LEO 29102 0.1 mg/g cream | Experimental |
| |
| LEO 29102 0.3 mg/g cream | Experimental |
| |
| LEO 29102 1.0 mg/g cream | Experimental |
| |
| LEO 29102 2.5 mg/g cream | Experimental |
| |
| LEO 29102 cream vehicle | Placebo Comparator |
| |
| Elidel® cream (pimecrolimus) 10 mg/g | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 29102 | Drug | comparison of different dosages of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent
The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country. | Baseline (Day 0) and end of treatment (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Symptom Free Responders (LOCF) | The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity: 0. Clear - no inflammatory signs of AD
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windsor Clinical Research Inc. | Windsor | Ontario | N8W 5L7 | Canada | ||
| Helsinki University Central Hospital |
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Participants received investigational medicinal products for up to 4-weeks followed by a 28 day follow-up period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LEO 29102 Vehicle | LEO 29102 cream vehicle applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total body surface area (BSA) for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an investigator's global assessment [IGA] of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Visit 6 (Day 56). The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. |
| FG001 | LEO 29102 0.03 mg/g | LEO 29102 0.03 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. |
| FG002 | LEO 29102 0.1 mg/g | LEO 29102 0.1 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. |
| FG003 | LEO 29102 0.3 mg/g | LEO 29102 0.3 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. |
| FG004 | LEO 29102 1.0 mg/g | LEO 29102 1.0 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participant had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised. |
| FG005 | LEO 29102 2.5 mg/g | LEO 29102 2.5 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised. |
| FG006 | Elidel® 10 mg/g | Elidel® applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LEO 29102 Vehicle | Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks |
| BG001 | LEO 29102 0.03 mg/g | Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| 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 | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent
The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline (Day 0) and end of treatment (Day 28) |
|
From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
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 29102 Cream Vehicle - Treatment Phase | Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592443 | 2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide |
| C117268 | pimecrolimus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Elidel® | Drug | comparison |
|
| At end of treatment (Day 28) |
| Participants' Assessment of Pruritus on Trunk and Limbs | Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below.
The assessment was based on the average degree of pruritus over the last 24 hours. | At end of treatment (Day 28) |
| Participants' Overall Assessment of Disease Severity | Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe. The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit. | At end of treatment (Day 28) |
| Number of Participants That Were Symptom Free Responders by Visit | Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment. | At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28) |
| Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent
| Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) |
| Helsinki |
| 00250 |
| Finland |
| Klinik und Poliklinik für Dermatologie, Universität Bonn | Bonn | 53105 | Germany |
| BG002 | LEO 29102 0.1 mg/g | Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| BG003 | LEO 29102 0.3 mg/g | Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| BG004 | LEO 29102 1.0 mg/g | Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| BG005 | LEO 29102 2.5 mg/g | Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| BG006 | Elidel® 10 mg/g | Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | LEO 29102 0.03 mg/g | Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| OG002 | LEO 29102 0.1 mg/g | Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| OG003 | LEO 29102 0.3 mg/g | Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| OG004 | LEO 29102 1.0 mg/g | Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks |
| OG005 | LEO 29102 2.5 mg/g | Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week |
| OG006 | Elidel® 10 mg/g | Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks |
|
|
|
| Secondary | Number of Participants That Were Symptom Free Responders (LOCF) | The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity: 0. Clear - no inflammatory signs of AD
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment. | Posted | Count of Participants | Participants | At end of treatment (Day 28) |
|
|
|
| Secondary | Participants' Assessment of Pruritus on Trunk and Limbs | Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below.
The assessment was based on the average degree of pruritus over the last 24 hours. | Posted | Count of Participants | Participants | At end of treatment (Day 28) |
|
|
|
| Secondary | Participants' Overall Assessment of Disease Severity | Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe. The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit. | Posted | Count of Participants | Participants | At end of treatment (Day 28) |
|
|
|
| Secondary | Number of Participants That Were Symptom Free Responders by Visit | Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment. | Occurrences of early withdrawal, non-compliance, prohibited medication, missing application of study medication and participants missing visits resulted in not all participants being analyzed at all visits. | Posted | Count of Participants | Participants | At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28) |
|
|
|
| Secondary | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent
| Data was tabulated using an observed cases approach and therefore only contains data from participants who attended the specific visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) |
|
|
|
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | LEO 29102 0.03 mg/g Cream - Treatment Phase | Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 24 | 11 | 24 |
| EG002 | LEO 29102 0.1 mg/g Cream - Treatment Phase | Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 8 | 25 |
| EG003 | LEO 29102 0.3 mg/g Cream - Treatment Phase | Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 8 | 25 |
| EG004 | LEO 29102 1.0 mg/g Cream - Treatment Phase | Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 28 | 8 | 28 |
| EG005 | LEO 29102 2.5 mg/g Cream - Treatment Phase | Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 30 | 8 | 30 |
| EG006 | Elidel® Cream (Pimecrolimus) 10 mg/g - Treatment Phase | Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 8 | 25 |
| EG007 | LEO 29102 Cream Vehicle - Follow-up Phase | Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 1 | 25 |
| EG008 | LEO 29102 0.03 mg/g Cream - Follow-up Phase | Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 24 | 0 | 24 |
| EG009 | LEO 29102 0.1 mg/g Cream - Follow-up Phase | Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 2 | 25 |
| EG010 | LEO 29102 0.3 mg/g Cream - Follow-up Phase | Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 0 | 25 |
| EG011 | LEO 29102 1.0 mg/g Cream - Follow-up Phase | Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 28 | 2 | 28 |
| EG012 | LEO 29102 2.5 mg/g Cream - Follow-up Phase | Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 30 | 4 | 30 |
| EG013 | Elidel® 10 mg/g - Follow-up Phase | Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks | 0 | 25 | 2 | 25 |
| Conjunctivitis allergic | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application site vesicles | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Herpes simplex ophthalmic | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cholestatic pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA (6.1) | Non-systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA (6.1) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Non-responder |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Very mild |
|
| Mild |
|
| Moderate |
|
| Severe |
|
|
| Visit 3 (Day 14) |
|
|
| Visit 4 (Day 21) |
|
|
| Visit 5 (Day 28) |
|
|
|
| Visit 3 (Day 14) |
|
|
| Visit 4 (Day 21) |
|
|
| Non-responder |
|
| Non-responder |
|
| Non-responder |
|