A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Official Title
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A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: B LEO 35299 20 mg/g cream
* Drug: C LEO 35299 20 mg/g cream
* Drug: E LEO 35299 10 mg/g solution
* Drug: F LEO 35299 10 mg/g solution
* Drug: Daivonex® ointment
* Drug: Daivonex® ointment vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out. Age 18 years or above. Males, or females of non-child bearing potential. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline). Exclusion Criteria: Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application. Female subjects who are pregnant, of child-bearing potential or who are breast feeding. 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 islonger) for experimental biological products prior to randomisation and during the study. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study: - Potent or very potent (WHO group III-IV) corticosteroids. Subjects using of phototherapy within the following time periods prior to randomisation and during the study: PUVA (4 weeks) UVB (2 weeks) Subjects using one of the following topical drugs for the treatment of psoriasis within two 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. macrolides) Anthracen derivatives Tar, Salicylic acid. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview 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) Subjects with current participation in any other interventional clinical, based on interview of the subject

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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: B LEO 35299 20 mg/g cream|once daily application, 3 weeks|
|Drug: C LEO 35299 20 mg/g cream|once daily application, 3 weeks|
|Drug: E LEO 35299 10 mg/g solution|once daily application, 3 weeks|
|Drug: F LEO 35299 10 mg/g solution|once daily application, 3 weeks|
|Drug: Daivonex® ointment|once daily application, 3 weeks|
|Drug: Daivonex® ointment vehicle|once daily application, 3 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Total Clinical Score From Baseline to Day 22 | Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe) | Baseline to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Erythema From Baseline to Day 22 | Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). | Baseline to Day 22 | 
| Change in Infiltration From Baseline to Day 22 | Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). | Baseline to Day 22 | 
| Change in Scaling From Baseline to Day 22 | Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent). | Baseline to Day 22 | 
| Change in Lesion Thickness From Baseline to Day 22 | Change in total skin thickness measured by ultrasound from baseline to end of treatment | Baseline to Day 22 | 
| Change in Skin Thickness From Baseline to Day 22 | Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment | Baseline to Day 22 |