A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test

Study Overview
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Brief Summary
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To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris

Detailed Description
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The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments. Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.

Official Title
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A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Ointment In A Psoriasis Plaque Test

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AN2728 Ointment, 5%
* Drug: AN2728 Ointment, 2%
* Drug: AN2728 Ointment, 0.5%
* Drug: AN2728 Ointment Vehicle
* Drug: Betnesol®-V Creme, 0.1%
* Drug: Protopic® Ointment, 0.1 %


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male subjects aged 18 years or older; subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six treatment fields; the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; written informed consent obtained. Exclusion Criteria: subjects who require systemically acting medications for the treatment of psoriasis, which might counter or influence the study objectives, e.g. corticosteroids, cytostatics; local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks); systemic treatment with antipsoriatics in the three months preceding and during the study; treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. β-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study; known allergic reactions to the active ingredients or other components of the study preparations or comparators; evidence of drug abuse; UV-therapy within four weeks before beginning and during the study; symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study; in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent. subject is institutionalized because of legal or regulatory order.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AN2728 Ointment, 5% | Drug: AN2728 Ointment, 5%<br> <br> |
| Experimental: 2<br>AN2728 Ointment, 2% | Drug: AN2728 Ointment, 2%<br> <br> |
| Experimental: 3<br>AN2728 Ointment, 0.5% | Drug: AN2728 Ointment, 0.5%<br> <br> |
| Placebo Comparator: 4<br>AN2728 Ointment Vehicle | Drug: AN2728 Ointment Vehicle<br> <br> |
| Active Comparator: 5<br>Betnesol®-V Creme (betamethasone 0.1 %) | Drug: Betnesol®-V Creme, 0.1%<br> <br> * Other names: betamethasone 0.1%;|
| Active Comparator: 6<br>Protopic® Ointment (tacrolimus 0.1 %) | Drug: Protopic® Ointment, 0.1 %<br> <br> * Other names: tacrolimus 0.1 %;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12 |  | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infiltrate Thickness |  | Day 8 | 
| Sonographic Measurements of Infiltrate Thickness |  | Day 8, Day 12 | 
| The AUC of the Infiltrate Thickness |  | Day 8, Day 12 | 
| Clinical Assessment Scores for Assessment of Efficacy |  | Day 8, Day 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Type Psoriasis, Topical