Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test

Study Overview
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Brief Summary
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Evaluate the effects of topical C-82 in a psoriasis plaque test.

Detailed Description
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The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.

Official Title
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A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: C-82 Topical Gel, Placebo
* Drug: C-82 Topical Gel, 1%
* Drug: Daivonex cream
* Drug: Diprosis gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate chronic stable plaque type psoriasis plaques thickness of at least 200 µm lesion(s) on the trunk or extremities (excluding palms/soles) skin must be without disease findings Exclusion Criteria: other skin disease psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial treatment with any biologics within 3 months preceding and during the trial known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol) drug or alcohol abuse symptoms of a clinically significant illness within 4 preceding and during the trial participation another clinical trial within 4 weeks of this clinical trial

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
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMP 1<br>C-82 Topical Gel, 1% | Drug: C-82 Topical Gel, 1%<br>* active<br>|
| Placebo Comparator: IMP 2<br>C-82 Topical Gel, placebo | Drug: C-82 Topical Gel, Placebo<br>* placebo<br>|
| Active Comparator: IMP 3<br>Daivonex cream | Drug: Daivonex cream<br>* comparator<br>* Other names: calcipotriol 50mcg/g;|
| Active Comparator: IMP 4<br>Diprosis gel | Drug: Diprosis gel<br>* comparator<br>* Other names: betamethasone, 0.5 mg/g;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate |  | day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antipsoriatic efficacy compared to control by clinical assessment using a 5-point score. |  | Day 8 & Day 12 | 
| number of subjects with adverse events |  | daily through Day 12 |