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The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 29102 cream | Experimental | LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks |
|
| LEO 29102 Cream Vehicle | Placebo Comparator | LEO 29102 cream vehicle applied topically twice daily for 4 weeks. |
|
| Betamethasone Dipropionate Cream | Experimental | Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
|
| LEO 29102 Plus Calcipotriol Cream | Experimental | LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. |
|
| LEO 29102 Plus Betamethasone Dipropionate | Experimental | LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
|
| Daivobet® Ointment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 29102 cream | Drug |
| ||
| LEO 29102 Cream Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). | From baseline (Day 1) to end of treatment (Day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). |
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Inclusion Criteria: (in summary)
Exclusion Criteria: (in summary)
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| Name | Affiliation | Role |
|---|---|---|
| Director, International Clinical Development, MD | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma site | Saint-Quentin-en-Yvelines | France |
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Participants were treated with the investigational medicinal products for 4 weeks followed by a 10-day follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Randomized Participants | All randomized participants received the six investigational medicinal products on six different test sites. LEO 29102 cream, LEO 29102 plus calcipotriol cream, LEO 29102 plus betamethasone dipropionate cream, Daivobet® ointment, Betamethasone dipropionate cream, and LEO 29102 cream vehicle applied topically once daily six times a week for 4 weeks (not on Sundays) on six different 2-cm diameter site (one per study preparation). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants received the six products on six different test sites. |
| 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 | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | score on a scale | From baseline (Day 1) to end of treatment (Day 29) |
From baseline to end of Follow-up (Day 43±2)
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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 | All Randomized Participants | All randomized participants received the six products on six different test sites. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| C000592443 | 2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide |
| C011175 | betamethasone-17,21-dipropionate |
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| Active Comparator |
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks. |
|
|
| Betamethasone Dipropionate Cream | Drug |
|
| LEO 29102 Plus Calcipotriol Cream | Drug |
|
| LEO 29102 Plus Betamethasone Dipropionate | Drug |
|
| Daivobet® Ointment | Drug |
|
| From baseline (Day 1) to end of treatment (Day 29) |
| Change in Erythema Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25 |
| Change in Scaling Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
| Change in Infiltration Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
| Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
| Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment. | At Day 8, Day 15, Day 22 and end of treatment |
| Biomarkers by Immunochemistry | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. Cells counted per mm^2 were cells that were positive for the indicated biomarker. | At end of treatment |
| Biomarkers by Immunochemistry: Epidermal Differentiation | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. | At end of treatment |
| Biomarkers by Immunochemistry: Epidermal Proliferation | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker. | At end of treatment |
| Pathology and Histology by Treatment | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:
| At end of treatment |
| Pathology and Histology by Treatment: Epidermal Thickness | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections.. | At end of treatment |
| Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections. | At end of treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | LEO 29102 Cream Vehicle | LEO 29102 cream vehicle applied topically twice daily for 4 weeks. |
| OG001 | Betamethasone Dipropionate Cream | Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
| OG002 | LEO 29102 Cream | LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks. |
| OG003 | LEO 29102 Plus Calcipotriol Cream | LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. |
| OG004 | LEO 29102 Plus Betamethasone Dipropionate | LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
| OG005 | Daivobet® Ointment | Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks. |
|
|
|
| Secondary | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | score on a scale | From baseline (Day 1) to end of treatment (Day 29) |
|
|
|
| Secondary | Change in Erythema Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | units on a scale | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25 |
|
|
|
| Secondary | Change in Scaling Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | units on a scale | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
|
|
|
| Secondary | Change in Infiltration Compared to Baseline | The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | units on a scale | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
|
|
|
| Secondary | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe). | Posted | Mean | Standard Deviation | score on a scale | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 |
|
|
|
| Secondary | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment. | The 24 participants that were randomized received all products distributed on six different test sites on the body. | Posted | Mean | Standard Deviation | mm | At Day 8, Day 15, Day 22 and end of treatment |
|
|
|
| Secondary | Biomarkers by Immunochemistry | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. Cells counted per mm^2 were cells that were positive for the indicated biomarker. | Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | cells/mm^2 | At end of treatment |
|
|
|
| Secondary | Biomarkers by Immunochemistry: Epidermal Differentiation | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. | Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | %, positive area/total area | At end of treatment |
|
|
|
| Secondary | Biomarkers by Immunochemistry: Epidermal Proliferation | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker. | Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | cells/mm^2 | At end of treatment |
|
|
|
| Secondary | Pathology and Histology by Treatment | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:
| Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | score on a scale | At end of treatment |
|
|
|
| Secondary | Pathology and Histology by Treatment: Epidermal Thickness | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections.. | Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | µm | At end of treatment |
|
|
|
| Secondary | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections. | Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available. | Posted | Mean | Standard Deviation | cells/mm^2 | At end of treatment |
|
|
|
| 0 |
| 24 |
| 8 |
| 24 |
| Diverticulitis | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Postoperative infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
LEO retains the right to publish the results of this clinical trial.
| Infiltration |
|
| Scaliness |
|
| Visit 8 (Day 8) |
|
| Visit 11 (Day 11) |
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| Visit 14 (Day 15) |
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| Visit 17 (Day 18) |
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| Visit 20 (Day 22) |
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| Visit 23 (Day 25) |
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| Visit 8 (Day 8) |
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| Visit 11 (Day 11) |
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| Visit 14 (Day 15) |
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| Visit 17 (Day 18) |
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| Visit 20 (Day 22) |
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| Visit 23 (Day 25) |
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| Visit 8 (Day 8) |
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| Visit 11 (Day 11) |
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| Visit 14 (Day 15) |
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| Visit 17 (Day 18) |
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| Visit 20 (Day 22) |
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| Visit 23 (Day 25) |
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| Visit 8 (Day 8) |
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| Visit 11 (Day 11) |
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| Visit 14 (Day 15) |
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| Visit 17 (Day 18) |
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| Visit 20 (Day 22) |
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| Visit 23 (Day 25) |
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| Visit 14 (Day 15) |
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| Visit 20 (Day 22) |
|
| Visit 26 (Day 29) |
|
|
| Dendritic cells CD1a |
|
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| T-cell biomarker CD3 |
|
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| Angiogenesis: CD31 |
|
|
| T-cell biomarker: CD4 |
|
|
| T-cell biomarker: CD45RO |
|
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| Macrophages: CD68 |
|
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| T-cell biomarker: CD8 |
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| Epidermal differentiation: CK16 |
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| Parakeratosis |
|
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| Stratum Corneum |
|
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| Stratum Granulosum |
|
|