A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

Detailed Description
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The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Official Title
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A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris

Conditions
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Skin and Connective Tissue Diseases

Intervention / Treatment
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* Drug: LEO 90100 Aerosol foam
* Drug: Betesil® 2.25 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent has been obtained Subjects with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites. Age 18 years or above Outpatients Female subjects must be of either non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. Exclusion Criteria: Female subjects who are breast feeding Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: Etanercept - within 4 weeks prior to randomisation and during the trial Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial Ustekinumab - within 16 weeks prior to randomisation and during the trial Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer) Systemic treatment 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 trial Subjects using phototherapy within the following time periods prior to randomisation and during the trial: PUVA: 4 weeks UVB: 2 weeks Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial: Potent or very potent (WHO group III-IV) corticosteroids Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: 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), Tar products, Salicylic acid Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEO 90100 Aerosol foam<br>Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam) | Drug: LEO 90100 Aerosol foam<br> <br> |
| Active Comparator: Betesil® 2.25 mg<br>Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).(Betesil® ) | Drug: Betesil® 2.25 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment 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 with half-mark values from 0 (no evidence) to 3.0 (severe). The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups. | Day 1 (Baseline) to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TCS at Individual Visits |  | Day 1 (Baseline) to Day 29 | 
| Change in Score of Erythema, Scaling, and Infiltration at Individual Visits | The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration). | Day 1 (Baseline) to Day 29 | 
| Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT | Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment. Two skin parameters were calculated using ultrasound: The mean total skin thickness The mean echo-poor band thickness | Baseline to End of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis