Psoriasis Vulgaris
Conditions
Brief summary
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.
Interventions
DRUGLEO 29102 cream
DRUGLEO 29102 Plus Calcipotriol Cream
DRUGLEO 29102 Plus Betamethasone Dipropionate
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(in summary) * Subjects having understood and signed an informed consent form * All skin types * Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable * Subjects willing and able to follow all the study procedures and complete the whole study * Subjects affiliated to social security system
Exclusion criteria
(in summary) * Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding * Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration * Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation * Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy * Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy * Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | From baseline (Day 1) to end of treatment (Day 29) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erythema Compared to Baseline | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25 | 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 |
| Change in Scaling Compared to Baseline | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 | 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 |
| Change in Infiltration Compared to Baseline | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 | 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 |
| Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25 | 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). |
| Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | At Day 8, Day 15, Day 22 and end of treatment | The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment. |
| Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | From baseline (Day 1) to end of treatment (Day 29) | 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). |
| Biomarkers by Immunochemistry: Epidermal Differentiation | At end of treatment | 3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. |
| Biomarkers by Immunochemistry: Epidermal Proliferation | At end of treatment | 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. |
| Pathology and Histology by Treatment | At end of 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: * Morphology of epidermis * Stratum corneum (semi (extent of)) * Stratum granulosum (semi (extent of)) * Parakeratosis (semi (extent of)) * Infiltration of inflammatory cells (semi (extent of)) |
| Pathology and Histology by Treatment: Epidermal Thickness | At end of 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. 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.. |
| Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | At end of 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. 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. |
| Biomarkers by Immunochemistry | At end of treatment | 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. |
Countries
France
Participant flow
Recruitment details
Participants were treated with the investigational medicinal products for 4 weeks followed by a 10-day follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants received the six products on six different test sites. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment France | 24 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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).
Time frame: From baseline (Day 1) to end of treatment (Day 29)
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -1.60 score on a scale | Standard Deviation 1.18 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -4.96 score on a scale | Standard Deviation 1.99 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -3.04 score on a scale | Standard Deviation 1.34 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -3.96 score on a scale | Standard Deviation 1.49 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -5.56 score on a scale | Standard Deviation 1.28 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) | -6.10 score on a scale | Standard Deviation 1.06 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.035t-test, 2 sided
p-value: 0.082t-test, 2 sided
p-value: 0.009t-test, 2 sided
p-value: 0.012t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.089t-test, 2 sided
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.
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 593.8 cells/mm^2 | Standard Deviation 243.9 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | Macrophages: CD163 | 313.9 cells/mm^2 | Standard Deviation 97.28 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | Dendritic cells CD1a | 233.8 cells/mm^2 | Standard Deviation 113.9 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 430.7 cells/mm^2 | Standard Deviation 165.7 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 284.3 cells/mm^2 | Standard Deviation 123.9 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 752.0 cells/mm^2 | Standard Deviation 183.1 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | Macrophages: CD68 | 370.8 cells/mm^2 | Standard Deviation 58.56 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 280.5 cells/mm^2 | Standard Deviation 156 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 216.3 cells/mm^2 | Standard Deviation 100.1 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 60.05 cells/mm^2 | Standard Deviation 61.95 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | Macrophages: CD68 | 120.3 cells/mm^2 | Standard Deviation 61.57 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 101.6 cells/mm^2 | Standard Deviation 78.14 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | Macrophages: CD163 | 197.4 cells/mm^2 | Standard Deviation 69.51 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 124.5 cells/mm^2 | Standard Deviation 105.9 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | Dendritic cells CD1a | 42.14 cells/mm^2 | Standard Deviation 27.81 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 59.17 cells/mm^2 | Standard Deviation 41.78 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | Dendritic cells CD1a | 229.3 cells/mm^2 | Standard Deviation 134.2 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 464.2 cells/mm^2 | Standard Deviation 275.9 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 331.1 cells/mm^2 | Standard Deviation 120.9 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 220.7 cells/mm^2 | Standard Deviation 123.9 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 246.4 cells/mm^2 | Standard Deviation 148 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 630.1 cells/mm^2 | Standard Deviation 318.8 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | Macrophages: CD68 | 323.1 cells/mm^2 | Standard Deviation 114.2 |
| LEO 29102 Cream | Biomarkers by Immunochemistry | Macrophages: CD163 | 291.2 cells/mm^2 | Standard Deviation 100.8 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | Macrophages: CD68 | 303.8 cells/mm^2 | Standard Deviation 117.8 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 643.6 cells/mm^2 | Standard Deviation 370.4 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 239.0 cells/mm^2 | Standard Deviation 147.3 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | Macrophages: CD163 | 383.5 cells/mm^2 | Standard Deviation 488.6 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 492.7 cells/mm^2 | Standard Deviation 280.4 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 348.8 cells/mm^2 | Standard Deviation 158.1 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 253.2 cells/mm^2 | Standard Deviation 171.9 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry | Dendritic cells CD1a | 244.0 cells/mm^2 | Standard Deviation 118.9 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 66.35 cells/mm^2 | Standard Deviation 53.3 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | Macrophages: CD163 | 178.2 cells/mm^2 | Standard Deviation 27.96 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 55.56 cells/mm^2 | Standard Deviation 44.03 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 121.6 cells/mm^2 | Standard Deviation 50.39 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | Dendritic cells CD1a | 34.31 cells/mm^2 | Standard Deviation 20 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | Macrophages: CD68 | 142.1 cells/mm^2 | Standard Deviation 58.47 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 126.1 cells/mm^2 | Standard Deviation 95.57 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 184.2 cells/mm^2 | Standard Deviation 38.84 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | T-cell biomarker: CD4 | 66.95 cells/mm^2 | Standard Deviation 55.07 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | Macrophages: CD68 | 156.8 cells/mm^2 | Standard Deviation 44.82 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | T-cell biomarker CD3 | 143.9 cells/mm^2 | Standard Deviation 161.5 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | Angiogenesis: CD31 | 186.6 cells/mm^2 | Standard Deviation 51.62 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | T-cell biomarker: CD45RO | 218.2 cells/mm^2 | Standard Deviation 258.7 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | Dendritic cells CD1a | 56.34 cells/mm^2 | Standard Deviation 33.81 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | T-cell biomarker: CD8 | 65.05 cells/mm^2 | Standard Deviation 72 |
| Daivobet® Ointment | Biomarkers by Immunochemistry | Macrophages: CD163 | 172.9 cells/mm^2 | Standard Deviation 40.61 |
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.
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.76 %, positive area/total area | Standard Deviation 0.14 |
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.11 %, positive area/total area | Standard Deviation 0.14 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.89 %, positive area/total area | Standard Deviation 0.15 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.00 %, positive area/total area | Standard Deviation 0 |
| LEO 29102 Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.77 %, positive area/total area | Standard Deviation 0.14 |
| LEO 29102 Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.08 %, positive area/total area | Standard Deviation 0.11 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.75 %, positive area/total area | Standard Deviation 0.11 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.02 %, positive area/total area | Standard Deviation 0.04 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.93 %, positive area/total area | Standard Deviation 0.08 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.01 %, positive area/total area | Standard Deviation 0.01 |
| Daivobet® Ointment | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK10 | 0.89 %, positive area/total area | Standard Deviation 0.25 |
| Daivobet® Ointment | Biomarkers by Immunochemistry: Epidermal Differentiation | Epidermal differentiation: CK16 | 0.00 %, positive area/total area | Standard Deviation 0.01 |
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.
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 29102 Cream Vehicle | Biomarkers by Immunochemistry: Epidermal Proliferation | 554.1 cells/mm^2 | Standard Deviation 391.9 |
| Betamethasone Dipropionate Cream | Biomarkers by Immunochemistry: Epidermal Proliferation | 19.45 cells/mm^2 | Standard Deviation 28.69 |
| LEO 29102 Cream | Biomarkers by Immunochemistry: Epidermal Proliferation | 443.3 cells/mm^2 | Standard Deviation 298.6 |
| LEO 29102 Plus Calcipotriol Cream | Biomarkers by Immunochemistry: Epidermal Proliferation | 354.3 cells/mm^2 | Standard Deviation 198.2 |
| LEO 29102 Plus Betamethasone Dipropionate | Biomarkers by Immunochemistry: Epidermal Proliferation | 20.50 cells/mm^2 | Standard Deviation 29.11 |
| Daivobet® Ointment | Biomarkers by Immunochemistry: Epidermal Proliferation | 93.49 cells/mm^2 | Standard Deviation 134.9 |
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
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -0.40 units on a scale | Standard Deviation 0.36 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -0.23 units on a scale | Standard Deviation 0.33 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.08 units on a scale | Standard Deviation 0.38 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -0.44 units on a scale | Standard Deviation 0.4 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -0.46 units on a scale | Standard Deviation 0.49 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.04 units on a scale | Standard Deviation 0.25 |
| LEO 29102 Cream Vehicle | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -0.42 units on a scale | Standard Deviation 0.43 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -1.48 units on a scale | Standard Deviation 0.8 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -1.33 units on a scale | Standard Deviation 0.76 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.21 units on a scale | Standard Deviation 0.29 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.67 units on a scale | Standard Deviation 0.46 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -0.94 units on a scale | Standard Deviation 0.47 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -1.23 units on a scale | Standard Deviation 0.69 |
| Betamethasone Dipropionate Cream | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -1.54 units on a scale | Standard Deviation 0.81 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -0.75 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -0.83 units on a scale | Standard Deviation 0.55 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.02 units on a scale | Standard Deviation 0.18 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -0.60 units on a scale | Standard Deviation 0.36 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -0.85 units on a scale | Standard Deviation 0.54 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -0.46 units on a scale | Standard Deviation 0.33 |
| LEO 29102 Cream | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.31 units on a scale | Standard Deviation 0.32 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.29 units on a scale | Standard Deviation 0.29 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.08 units on a scale | Standard Deviation 0.24 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -1.08 units on a scale | Standard Deviation 0.5 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -0.44 units on a scale | Standard Deviation 0.37 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -0.77 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -0.98 units on a scale | Standard Deviation 0.4 |
| LEO 29102 Plus Calcipotriol Cream | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -1.04 units on a scale | Standard Deviation 0.51 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -1.71 units on a scale | Standard Deviation 0.61 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -1.17 units on a scale | Standard Deviation 0.43 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.92 units on a scale | Standard Deviation 0.43 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -1.75 units on a scale | Standard Deviation 0.66 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -1.83 units on a scale | Standard Deviation 0.72 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.40 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -1.46 units on a scale | Standard Deviation 0.59 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 20 (Day 22) | -1.85 units on a scale | Standard Deviation 0.6 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 17 (Day 18) | -1.63 units on a scale | Standard Deviation 0.56 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 8 (Day 8) | -0.88 units on a scale | Standard Deviation 0.56 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 11 (Day 11) | -1.19 units on a scale | Standard Deviation 0.66 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 14 (Day 15) | -1.40 units on a scale | Standard Deviation 0.66 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 23 (Day 25) | -1.94 units on a scale | Standard Deviation 0.54 |
| Daivobet® Ointment | Change in Erythema Compared to Baseline | Visit 5 (Day 4) | -0.38 units on a scale | Standard Deviation 0.42 |
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
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.06 units on a scale | Standard Deviation 0.31 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -0.33 units on a scale | Standard Deviation 0.35 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -0.38 units on a scale | Standard Deviation 0.34 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -0.31 units on a scale | Standard Deviation 0.29 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | -0.06 units on a scale | Standard Deviation 0.27 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -0.13 units on a scale | Standard Deviation 0.37 |
| LEO 29102 Cream Vehicle | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -0.25 units on a scale | Standard Deviation 0.33 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | -0.10 units on a scale | Standard Deviation 0.29 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -1.10 units on a scale | Standard Deviation 0.61 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -1.35 units on a scale | Standard Deviation 0.73 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.38 units on a scale | Standard Deviation 0.34 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -0.77 units on a scale | Standard Deviation 0.51 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -1.25 units on a scale | Standard Deviation 0.66 |
| Betamethasone Dipropionate Cream | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -0.98 units on a scale | Standard Deviation 0.6 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -0.58 units on a scale | Standard Deviation 0.46 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -0.31 units on a scale | Standard Deviation 0.38 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | -0.04 units on a scale | Standard Deviation 0.2 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -0.42 units on a scale | Standard Deviation 0.43 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.13 units on a scale | Standard Deviation 0.34 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -0.56 units on a scale | Standard Deviation 0.47 |
| LEO 29102 Cream | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -0.73 units on a scale | Standard Deviation 0.47 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -0.69 units on a scale | Standard Deviation 0.38 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | 0.00 units on a scale | Standard Deviation 0.21 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.29 units on a scale | Standard Deviation 0.51 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -0.46 units on a scale | Standard Deviation 0.39 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -0.75 units on a scale | Standard Deviation 0.39 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -0.90 units on a scale | Standard Deviation 0.33 |
| LEO 29102 Plus Calcipotriol Cream | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -1.06 units on a scale | Standard Deviation 0.4 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -1.06 units on a scale | Standard Deviation 0.5 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.73 units on a scale | Standard Deviation 0.47 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -1.67 units on a scale | Standard Deviation 0.6 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | -0.27 units on a scale | Standard Deviation 0.25 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -1.67 units on a scale | Standard Deviation 0.62 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -1.35 units on a scale | Standard Deviation 0.65 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -1.50 units on a scale | Standard Deviation 0.63 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 23 (Day 25) | -2.02 units on a scale | Standard Deviation 0.54 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 17 (Day 18) | -1.94 units on a scale | Standard Deviation 0.61 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 11 (Day 11) | -1.29 units on a scale | Standard Deviation 0.62 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 8 (Day 8) | -0.79 units on a scale | Standard Deviation 0.44 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 20 (Day 22) | -1.98 units on a scale | Standard Deviation 0.52 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 5 (Day 4) | -0.29 units on a scale | Standard Deviation 0.33 |
| Daivobet® Ointment | Change in Infiltration Compared to Baseline | Visit 14 (Day 15) | -1.79 units on a scale | Standard Deviation 0.59 |
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
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.17 units on a scale | Standard Deviation 0.35 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -0.65 units on a scale | Standard Deviation 0.45 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -0.27 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -0.75 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -0.40 units on a scale | Standard Deviation 0.33 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -0.54 units on a scale | Standard Deviation 0.29 |
| LEO 29102 Cream Vehicle | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -0.52 units on a scale | Standard Deviation 0.52 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -0.88 units on a scale | Standard Deviation 0.61 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -1.33 units on a scale | Standard Deviation 0.64 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -1.15 units on a scale | Standard Deviation 0.54 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -1.56 units on a scale | Standard Deviation 0.6 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.31 units on a scale | Standard Deviation 0.41 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -1.81 units on a scale | Standard Deviation 0.6 |
| Betamethasone Dipropionate Cream | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -1.54 units on a scale | Standard Deviation 0.62 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -0.63 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -0.44 units on a scale | Standard Deviation 0.58 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.13 units on a scale | Standard Deviation 0.3 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -0.90 units on a scale | Standard Deviation 0.47 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -0.81 units on a scale | Standard Deviation 0.44 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -0.73 units on a scale | Standard Deviation 0.47 |
| LEO 29102 Cream | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -1.17 units on a scale | Standard Deviation 0.55 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -1.00 units on a scale | Standard Deviation 0.55 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.21 units on a scale | Standard Deviation 0.41 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -0.63 units on a scale | Standard Deviation 0.58 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -0.71 units on a scale | Standard Deviation 0.61 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -1.15 units on a scale | Standard Deviation 0.54 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -1.27 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Plus Calcipotriol Cream | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -1.46 units on a scale | Standard Deviation 0.57 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -1.48 units on a scale | Standard Deviation 0.58 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -1.17 units on a scale | Standard Deviation 0.67 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -2.00 units on a scale | Standard Deviation 0.42 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.33 units on a scale | Standard Deviation 0.43 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -1.75 units on a scale | Standard Deviation 0.53 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -1.67 units on a scale | Standard Deviation 0.58 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -1.83 units on a scale | Standard Deviation 0.58 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 23 (Day 25) | -2.21 units on a scale | Standard Deviation 0.36 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 17 (Day 18) | -2.13 units on a scale | Standard Deviation 0.49 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 11 (Day 11) | -1.92 units on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 8 (Day 8) | -1.19 units on a scale | Standard Deviation 0.48 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 20 (Day 22) | -2.19 units on a scale | Standard Deviation 0.38 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 5 (Day 4) | -0.52 units on a scale | Standard Deviation 0.38 |
| Daivobet® Ointment | Change in Scaling Compared to Baseline | Visit 14 (Day 15) | -2.04 units on a scale | Standard Deviation 0.49 |
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).
Time frame: From baseline (Day 1) to end of treatment (Day 29)
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -0.73 score on a scale | Standard Deviation 0.57 |
| LEO 29102 Cream Vehicle | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -0.42 score on a scale | Standard Deviation 0.48 |
| LEO 29102 Cream Vehicle | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -0.46 score on a scale | Standard Deviation 0.33 |
| Betamethasone Dipropionate Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -1.79 score on a scale | Standard Deviation 0.62 |
| Betamethasone Dipropionate Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -1.46 score on a scale | Standard Deviation 0.75 |
| Betamethasone Dipropionate Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -1.71 score on a scale | Standard Deviation 0.81 |
| LEO 29102 Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -0.90 score on a scale | Standard Deviation 0.55 |
| LEO 29102 Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -0.85 score on a scale | Standard Deviation 0.52 |
| LEO 29102 Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -1.29 score on a scale | Standard Deviation 0.51 |
| LEO 29102 Plus Calcipotriol Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -1.60 score on a scale | Standard Deviation 0.55 |
| LEO 29102 Plus Calcipotriol Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -1.17 score on a scale | Standard Deviation 0.5 |
| LEO 29102 Plus Calcipotriol Cream | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -1.19 score on a scale | Standard Deviation 0.7 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -1.75 score on a scale | Standard Deviation 0.53 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -1.96 score on a scale | Standard Deviation 0.41 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -1.85 score on a scale | Standard Deviation 0.63 |
| Daivobet® Ointment | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Erythema | -1.88 score on a scale | Standard Deviation 0.45 |
| Daivobet® Ointment | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Infiltration | -2.04 score on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline | Scaliness | -2.19 score on a scale | Standard Deviation 0.41 |
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).
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -1.54 score on a scale | Standard Deviation 0.97 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -0.42 score on a scale | Standard Deviation 0.78 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -0.27 score on a scale | Standard Deviation 0.66 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -1.42 score on a scale | Standard Deviation 0.95 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -1.31 score on a scale | Standard Deviation 0.83 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -0.75 score on a scale | Standard Deviation 0.75 |
| LEO 29102 Cream Vehicle | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -1.17 score on a scale | Standard Deviation 0.89 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -2.85 score on a scale | Standard Deviation 1.26 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -3.54 score on a scale | Standard Deviation 1.66 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -4.71 score on a scale | Standard Deviation 1.99 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -0.63 score on a scale | Standard Deviation 0.8 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -4.00 score on a scale | Standard Deviation 1.72 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -1.92 score on a scale | Standard Deviation 1.18 |
| Betamethasone Dipropionate Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -4.27 score on a scale | Standard Deviation 1.92 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -1.40 score on a scale | Standard Deviation 0.9 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -2.21 score on a scale | Standard Deviation 1.2 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -0.88 score on a scale | Standard Deviation 0.97 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -0.19 score on a scale | Standard Deviation 0.53 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -2.75 score on a scale | Standard Deviation 1.32 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -2.23 score on a scale | Standard Deviation 1.11 |
| LEO 29102 Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -1.75 score on a scale | Standard Deviation 1.12 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -1.60 score on a scale | Standard Deviation 1.11 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -2.88 score on a scale | Standard Deviation 0.99 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -2.46 score on a scale | Standard Deviation 1 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -3.60 score on a scale | Standard Deviation 1.25 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -1.21 score on a scale | Standard Deviation 1.07 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -3.21 score on a scale | Standard Deviation 0.98 |
| LEO 29102 Plus Calcipotriol Cream | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -0.29 score on a scale | Standard Deviation 0.66 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -5.17 score on a scale | Standard Deviation 1.64 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -1.00 score on a scale | Standard Deviation 0.88 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -2.81 score on a scale | Standard Deviation 1.26 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -5.50 score on a scale | Standard Deviation 1.47 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -3.71 score on a scale | Standard Deviation 1.28 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -4.48 score on a scale | Standard Deviation 1.56 |
| LEO 29102 Plus Betamethasone Dipropionate | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -5.04 score on a scale | Standard Deviation 1.46 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 17 (Day 18) | -5.69 score on a scale | Standard Deviation 1.3 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 14 (Day 15) | -5.23 score on a scale | Standard Deviation 1.41 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 20 (Day 22) | -6.02 score on a scale | Standard Deviation 1.08 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 11 (Day 11) | -4.40 score on a scale | Standard Deviation 1.42 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 23 (Day 25) | -6.17 score on a scale | Standard Deviation 0.87 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 8 (Day 8) | -2.85 score on a scale | Standard Deviation 1.17 |
| Daivobet® Ointment | Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline | Visit 5 (Day 4) | -1.19 score on a scale | Standard Deviation 0.86 |
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: * Morphology of epidermis * Stratum corneum (semi (extent of)) * Stratum granulosum (semi (extent of)) * Parakeratosis (semi (extent of)) * Infiltration of inflammatory cells (semi (extent of))
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 1.50 score on a scale | Standard Deviation 0.8 |
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment | Parakeratosis | 1.67 score on a scale | Standard Deviation 1.15 |
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment | Stratum Corneum | 1.83 score on a scale | Standard Deviation 0.83 |
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment | Stratum Granulosum | 1.42 score on a scale | Standard Deviation 1.24 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment | Stratum Corneum | 0.33 score on a scale | Standard Deviation 0.52 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment | Parakeratosis | 0.00 score on a scale | Standard Deviation 0 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 0.17 score on a scale | Standard Deviation 0.41 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment | Stratum Granulosum | 0.17 score on a scale | Standard Deviation 0.41 |
| LEO 29102 Cream | Pathology and Histology by Treatment | Stratum Granulosum | 1.04 score on a scale | Standard Deviation 1.26 |
| LEO 29102 Cream | Pathology and Histology by Treatment | Stratum Corneum | 1.52 score on a scale | Standard Deviation 0.9 |
| LEO 29102 Cream | Pathology and Histology by Treatment | Parakeratosis | 1.39 score on a scale | Standard Deviation 1.34 |
| LEO 29102 Cream | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 1.52 score on a scale | Standard Deviation 0.79 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 1.53 score on a scale | Standard Deviation 0.94 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment | Stratum Granulosum | 1.00 score on a scale | Standard Deviation 1.17 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment | Parakeratosis | 1.35 score on a scale | Standard Deviation 1.11 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment | Stratum Corneum | 1.41 score on a scale | Standard Deviation 0.94 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment | Stratum Corneum | 0.50 score on a scale | Standard Deviation 0.55 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment | Stratum Granulosum | 0.00 score on a scale | Standard Deviation 0 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment | Parakeratosis | 0.00 score on a scale | Standard Deviation 0 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 0.50 score on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Pathology and Histology by Treatment | Parakeratosis | 0.17 score on a scale | Standard Deviation 0.41 |
| Daivobet® Ointment | Pathology and Histology by Treatment | Stratum Corneum | 0.33 score on a scale | Standard Deviation 0.82 |
| Daivobet® Ointment | Pathology and Histology by Treatment | Stratum Granulosum | 0.17 score on a scale | Standard Deviation 0.41 |
| Daivobet® Ointment | Pathology and Histology by Treatment | Infiltration of inflammatory cells | 0.67 score on a scale | Standard Deviation 1.03 |
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..
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment: Epidermal Thickness | 254.6 µm | Standard Deviation 58.68 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment: Epidermal Thickness | 73.81 µm | Standard Deviation 20.61 |
| LEO 29102 Cream | Pathology and Histology by Treatment: Epidermal Thickness | 187.5 µm | Standard Deviation 79.65 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment: Epidermal Thickness | 176.4 µm | Standard Deviation 49.05 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment: Epidermal Thickness | 68.48 µm | Standard Deviation 18.16 |
| Daivobet® Ointment | Pathology and Histology by Treatment: Epidermal Thickness | 66.90 µm | Standard Deviation 44.53 |
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.
Time frame: At end of treatment
Population: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 29102 Cream Vehicle | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.14 cells/mm^2 | Standard Deviation 0.26 |
| Betamethasone Dipropionate Cream | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.00 cells/mm^2 | Standard Deviation 0 |
| LEO 29102 Cream | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.15 cells/mm^2 | Standard Deviation 0.35 |
| LEO 29102 Plus Calcipotriol Cream | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.17 cells/mm^2 | Standard Deviation 0.3 |
| LEO 29102 Plus Betamethasone Dipropionate | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.00 cells/mm^2 | Standard Deviation 0 |
| Daivobet® Ointment | Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses | 0.05 cells/mm^2 | Standard Deviation 0.13 |
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.
Time frame: At Day 8, Day 15, Day 22 and end of treatment
Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Cream Vehicle | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | 0.05 mm | Standard Deviation 0.22 |
| LEO 29102 Cream Vehicle | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.05 mm | Standard Deviation 0.23 |
| LEO 29102 Cream Vehicle | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.07 mm | Standard Deviation 0.27 |
| LEO 29102 Cream Vehicle | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.13 mm | Standard Deviation 0.3 |
| Betamethasone Dipropionate Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.54 mm | Standard Deviation 0.37 |
| Betamethasone Dipropionate Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.45 mm | Standard Deviation 0.39 |
| Betamethasone Dipropionate Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | -0.14 mm | Standard Deviation 0.32 |
| Betamethasone Dipropionate Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.63 mm | Standard Deviation 0.39 |
| LEO 29102 Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.30 mm | Standard Deviation 0.31 |
| LEO 29102 Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.15 mm | Standard Deviation 0.19 |
| LEO 29102 Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.16 mm | Standard Deviation 0.31 |
| LEO 29102 Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | 0.03 mm | Standard Deviation 0.24 |
| LEO 29102 Plus Calcipotriol Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | 0.00 mm | Standard Deviation 0.24 |
| LEO 29102 Plus Calcipotriol Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.38 mm | Standard Deviation 0.3 |
| LEO 29102 Plus Calcipotriol Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.25 mm | Standard Deviation 0.36 |
| LEO 29102 Plus Calcipotriol Cream | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.24 mm | Standard Deviation 0.32 |
| LEO 29102 Plus Betamethasone Dipropionate | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.57 mm | Standard Deviation 0.34 |
| LEO 29102 Plus Betamethasone Dipropionate | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.68 mm | Standard Deviation 0.34 |
| LEO 29102 Plus Betamethasone Dipropionate | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.51 mm | Standard Deviation 0.32 |
| LEO 29102 Plus Betamethasone Dipropionate | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | -0.30 mm | Standard Deviation 0.27 |
| Daivobet® Ointment | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 14 (Day 15) | -0.68 mm | Standard Deviation 0.46 |
| Daivobet® Ointment | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 20 (Day 22) | -0.68 mm | Standard Deviation 0.39 |
| Daivobet® Ointment | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 26 (Day 29) | -0.78 mm | Standard Deviation 0.43 |
| Daivobet® Ointment | Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound | Visit 8 (Day 8) | -0.39 mm | Standard Deviation 0.3 |