Psoriasis Vulgaris
Conditions
Brief summary
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Interventions
DRUGLEO90100 cutaneous spray, ointment
once daily application, 4 weeks
DRUGLEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
once daily application, 4 weeks
DRUGLEO 90100 cutaneous spray, ointment, vehicle
once daily application, 4 weeks
once daily application, 4 weeks
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects having signed and dated an informed consent 2. Age 18 years or above 3. Either sex 4. All skin types 5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk.
Exclusion criteria
1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding 2. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer)for experimental biological products prior to randomisation and during the study 3. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study 4. Use of phototherapy within the following time periods prior to randomisation and during the study: * PUVA or Grenz ray therapy (4 weeks) * UVB (2 weeks) 5. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study: * Potent or very potent (WHO group III-IV) corticosteroids 6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study: * WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis) * Topical retinoids * Vitamin D analogues * Topical immunomodulators (e.g. calcineurin inhibitors) * Anthracen derivatives * Tar * Salicylic acid 7. Subjects using emollients on the target plaques within one week before randomisation and during the study 8. Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study 9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history 11. Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin 12. 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 13. History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency) 14. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) 15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject 16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products 17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis 18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit 19. Subjects impossible to contact in case of emergency 20. Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state) 21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation 22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom 23. Subjects previously randomised in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | Day 1 (Baseline)/Day 29 | TCS range from 0 (all signs absent) to 9 (all signs severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Sign Scores | Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment) | Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement. |
| Changes in Total Clinical Score (TCS) by Visit | Baseline and Days 4, 8, 11, 15, 18, 22, 25 | Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline. |
| Change From Baseline in Echo-poor Band Thickness at End of Treatment | Baseline and Day 29 | Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound |
| Changes in Total Skin Thickness | Baseline and Days 8, 15, 22, and 29. | Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline |
Countries
France
Participant flow
Recruitment details
First Subject First Visit: 12-MAY-2011 Last Subject Last Visit: 20-JUN-2011
Pre-assignment details
The study was conducted with 3 successive individual phases: * Screening Phase (washout if applic.). A medical examination was performed at screening which took place 1-21 days before the start of the treatment phase (Day 1). * Treatment Phase (All patients (N=24) received all investigational medicinal products) * Follow-up Phase (if applic.)
Participants by arm
| Arm | Count |
|---|---|
| LEO 90100 Cutaneous Spray, Ointment Intra-Individual baseline analysis population, all treated with the following four products:
1. LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)
2. LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)
3. LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)
4. Daivobet® ointment: once daily application, 4 weeks (6 days a week) | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | LEO 90100 Cutaneous Spray, Ointment |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 15.8 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline
TCS range from 0 (all signs absent) to 9 (all signs severe).
Time frame: Day 1 (Baseline)/Day 29
Population: Intra-individual analysis population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 Cutaneous Spray, Ointment | Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | -6.00 Scores on a scale | Standard Deviation 1.27 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | -4.96 Scores on a scale | Standard Deviation 1.85 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | -1.88 Scores on a scale | Standard Deviation 1.12 |
| Daivobet® Ointment | Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | -5.25 Scores on a scale | Standard Deviation 1.78 |
Secondary
Change From Baseline in Echo-poor Band Thickness at End of Treatment
Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound
Time frame: Baseline and Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 Cutaneous Spray, Ointment | Change From Baseline in Echo-poor Band Thickness at End of Treatment | -0.57 millimetres | Standard Deviation 0.21 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change From Baseline in Echo-poor Band Thickness at End of Treatment | -0.45 millimetres | Standard Deviation 0.25 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change From Baseline in Echo-poor Band Thickness at End of Treatment | -0.12 millimetres | Standard Deviation 0.2 |
| Daivobet® Ointment | Change From Baseline in Echo-poor Band Thickness at End of Treatment | -0.46 millimetres | Standard Deviation 0.21 |
Secondary
Change in Clinical Sign Scores
Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement.
Time frame: Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 8) | -0.73 units on a scale | Standard Deviation 0.42 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 29) | -2.13 units on a scale | Standard Deviation 0.47 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 29) | -2.13 units on a scale | Standard Deviation 0.45 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 4) | -0.33 units on a scale | Standard Deviation 0.32 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 4) | -0.17 units on a scale | Standard Deviation 0.35 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 4) | -0.13 units on a scale | Standard Deviation 0.3 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 29) | -1.75 units on a scale | Standard Deviation 0.71 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 8) | -0.75 units on a scale | Standard Deviation 0.66 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 8) | -0.60 units on a scale | Standard Deviation 0.39 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 11) | -1.08 units on a scale | Standard Deviation 0.46 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 11) | -1.29 units on a scale | Standard Deviation 0.67 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 11) | -1.00 units on a scale | Standard Deviation 0.47 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 15) | -1.29 units on a scale | Standard Deviation 0.41 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 15) | -1.65 units on a scale | Standard Deviation 0.63 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 15) | -1.31 units on a scale | Standard Deviation 0.44 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 18) | -1.37 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 18) | -1.87 units on a scale | Standard Deviation 0.57 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 18) | -1.61 units on a scale | Standard Deviation 0.54 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 22) | -1.79 units on a scale | Standard Deviation 0.55 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 22) | -2.06 units on a scale | Standard Deviation 0.54 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 22) | -1.85 units on a scale | Standard Deviation 0.5 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Erythema (Day 25) | -1.79 units on a scale | Standard Deviation 0.53 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Scaling (Day 25) | -2.15 units on a scale | Standard Deviation 0.5 |
| LEO 90100 Cutaneous Spray, Ointment | Change in Clinical Sign Scores | Infiltration (Day 25) | -2.10 units on a scale | Standard Deviation 0.49 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 25) | -1.52 units on a scale | Standard Deviation 0.67 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 15) | -1.06 units on a scale | Standard Deviation 0.52 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 4) | -0.33 units on a scale | Standard Deviation 0.32 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 25) | -1.98 units on a scale | Standard Deviation 0.6 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 25) | -1.44 units on a scale | Standard Deviation 0.68 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 15) | -1.40 units on a scale | Standard Deviation 0.59 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 8) | -0.42 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 18) | -1.52 units on a scale | Standard Deviation 0.67 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 4) | -0.13 units on a scale | Standard Deviation 0.27 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 15) | -0.85 units on a scale | Standard Deviation 0.52 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 29) | -1.50 units on a scale | Standard Deviation 0.77 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 18) | -1.20 units on a scale | Standard Deviation 0.62 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 22) | -1.35 units on a scale | Standard Deviation 0.67 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 11) | -0.75 units on a scale | Standard Deviation 0.42 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 22) | -1.73 units on a scale | Standard Deviation 0.64 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 29) | -2.02 units on a scale | Standard Deviation 0.58 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 8) | -0.81 units on a scale | Standard Deviation 0.59 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 11) | -1.06 units on a scale | Standard Deviation 0.7 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 8) | -0.60 units on a scale | Standard Deviation 0.42 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 22) | -1.29 units on a scale | Standard Deviation 0.46 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Erythema (Day 29) | -1.44 units on a scale | Standard Deviation 0.78 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 11) | -0.58 units on a scale | Standard Deviation 0.52 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Scaling (Day 4) | -0.31 units on a scale | Standard Deviation 0.36 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Change in Clinical Sign Scores | Infiltration (Day 18) | -1.11 units on a scale | Standard Deviation 0.62 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 11) | -0.46 units on a scale | Standard Deviation 0.49 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 8) | -0.13 units on a scale | Standard Deviation 0.37 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 8) | -0.21 units on a scale | Standard Deviation 0.44 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 8) | -0.08 units on a scale | Standard Deviation 0.41 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 11) | -0.29 units on a scale | Standard Deviation 0.39 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 22) | -0.38 units on a scale | Standard Deviation 0.42 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 22) | -0.67 units on a scale | Standard Deviation 0.48 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 11) | -0.23 units on a scale | Standard Deviation 0.44 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 15) | -0.33 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 15) | -0.46 units on a scale | Standard Deviation 0.41 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 25) | -0.56 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 15) | -0.23 units on a scale | Standard Deviation 0.44 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 18) | -0.35 units on a scale | Standard Deviation 0.41 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 25) | -0.44 units on a scale | Standard Deviation 0.37 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 18) | -0.67 units on a scale | Standard Deviation 0.44 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 18) | -0.30 units on a scale | Standard Deviation 0.45 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 25) | -0.85 units on a scale | Standard Deviation 0.38 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 29) | -0.56 units on a scale | Standard Deviation 0.47 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 29) | -0.90 units on a scale | Standard Deviation 0.47 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 22) | -0.52 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 29) | -0.42 units on a scale | Standard Deviation 0.43 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Erythema (Day 4) | -0.19 units on a scale | Standard Deviation 0.25 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Scaling (Day 4) | -0.19 units on a scale | Standard Deviation 0.25 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Change in Clinical Sign Scores | Infiltration (Day 4) | -0.08 units on a scale | Standard Deviation 0.19 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 25) | -1.98 units on a scale | Standard Deviation 0.56 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 22) | -1.50 units on a scale | Standard Deviation 0.69 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 8) | -0.73 units on a scale | Standard Deviation 0.64 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 29) | -1.50 units on a scale | Standard Deviation 0.66 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 11) | -1.23 units on a scale | Standard Deviation 0.68 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 11) | -0.83 units on a scale | Standard Deviation 0.52 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 4) | -0.17 units on a scale | Standard Deviation 0.28 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 29) | -2.02 units on a scale | Standard Deviation 0.56 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 4) | -0.23 units on a scale | Standard Deviation 0.36 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 8) | -0.56 units on a scale | Standard Deviation 0.54 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 22) | -1.81 units on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 29) | -1.73 units on a scale | Standard Deviation 0.82 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 25) | -1.56 units on a scale | Standard Deviation 0.68 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 15) | -1.06 units on a scale | Standard Deviation 0.68 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 22) | -1.44 units on a scale | Standard Deviation 0.58 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 18) | -1.35 units on a scale | Standard Deviation 0.41 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 25) | -1.67 units on a scale | Standard Deviation 0.72 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 15) | -1.40 units on a scale | Standard Deviation 0.61 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 8) | -0.67 units on a scale | Standard Deviation 0.43 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Scaling (Day 18) | -1.74 units on a scale | Standard Deviation 0.64 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 15) | -1.04 units on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 11) | -0.90 units on a scale | Standard Deviation 0.55 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Erythema (Day 4) | -0.33 units on a scale | Standard Deviation 0.32 |
| Daivobet® Ointment | Change in Clinical Sign Scores | Infiltration (Day 18) | -1.43 units on a scale | Standard Deviation 0.7 |
Secondary
Changes in Total Clinical Score (TCS) by Visit
Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.
Time frame: Baseline and Days 4, 8, 11, 15, 18, 22, 25
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 4 | -0.63 Scores on a scale | Standard Deviation 0.65 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 22 | -5.71 Scores on a scale | Standard Deviation 1.17 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 18 | -4.85 Scores on a scale | Standard Deviation 1.17 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 8 | -2.08 Scores on a scale | Standard Deviation 1.17 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 25 | -6.04 Scores on a scale | Standard Deviation 1.15 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 11 | -3.38 Scores on a scale | Standard Deviation 1.17 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 15 | -4.25 Scores on a scale | Standard Deviation 1.07 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 22 | -4.38 Scores on a scale | Standard Deviation 1.49 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 15 | -3.31 Scores on a scale | Standard Deviation 1.31 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 11 | -2.40 Scores on a scale | Standard Deviation 1.38 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 18 | -3.83 Scores on a scale | Standard Deviation 1.66 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 25 | -4.94 Scores on a scale | Standard Deviation 1.68 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 8 | -1.83 Scores on a scale | Standard Deviation 1.03 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Clinical Score (TCS) by Visit | Day 4 | -0.77 Scores on a scale | Standard Deviation 0.71 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 15 | -1.02 Scores on a scale | Standard Deviation 0.94 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 4 | -0.46 Scores on a scale | Standard Deviation 0.36 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 8 | -0.42 Scores on a scale | Standard Deviation 0.83 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 11 | -0.98 Scores on a scale | Standard Deviation 0.87 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 18 | -1.33 Scores on a scale | Standard Deviation 1 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 22 | -1.56 Scores on a scale | Standard Deviation 1.08 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Clinical Score (TCS) by Visit | Day 25 | -1.85 Scores on a scale | Standard Deviation 0.88 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 11 | -2.96 Scores on a scale | Standard Deviation 1.41 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 25 | -5.21 Scores on a scale | Standard Deviation 1.68 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 22 | -4.75 Scores on a scale | Standard Deviation 1.52 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 8 | -1.96 Scores on a scale | Standard Deviation 1.28 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 4 | -0.73 Scores on a scale | Standard Deviation 0.71 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 18 | -4.52 Scores on a scale | Standard Deviation 1.42 |
| Daivobet® Ointment | Changes in Total Clinical Score (TCS) by Visit | Day 15 | -3.50 Scores on a scale | Standard Deviation 1.54 |
Secondary
Changes in Total Skin Thickness
Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline
Time frame: Baseline and Days 8, 15, 22, and 29.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Skin Thickness | Day 29 | -0.81 millimetres | Standard Deviation 0.41 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Skin Thickness | Day 8 | -0.37 millimetres | Standard Deviation 0.31 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Skin Thickness | Day 15 | -0.57 millimetres | Standard Deviation 0.38 |
| LEO 90100 Cutaneous Spray, Ointment | Changes in Total Skin Thickness | Day 22 | -0.68 millimetres | Standard Deviation 0.4 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Skin Thickness | Day 22 | -0.59 millimetres | Standard Deviation 0.35 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Skin Thickness | Day 15 | -0.40 millimetres | Standard Deviation 0.29 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Skin Thickness | Day 8 | -0.28 millimetres | Standard Deviation 0.19 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Changes in Total Skin Thickness | Day 29 | -0.66 millimetres | Standard Deviation 0.42 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Skin Thickness | Day 15 | -0.12 millimetres | Standard Deviation 0.23 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Skin Thickness | Day 22 | -0.18 millimetres | Standard Deviation 0.25 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Skin Thickness | Day 8 | -0.07 millimetres | Standard Deviation 0.21 |
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Changes in Total Skin Thickness | Day 29 | -0.23 millimetres | Standard Deviation 0.3 |
| Daivobet® Ointment | Changes in Total Skin Thickness | Day 8 | -0.33 millimetres | Standard Deviation 0.24 |
| Daivobet® Ointment | Changes in Total Skin Thickness | Day 29 | -0.62 millimetres | Standard Deviation 0.37 |
| Daivobet® Ointment | Changes in Total Skin Thickness | Day 22 | -0.59 millimetres | Standard Deviation 0.33 |
| Daivobet® Ointment | Changes in Total Skin Thickness | Day 15 | -0.49 millimetres | Standard Deviation 0.26 |