Study on the Therapeutic Mechanisms of Dithranol Treatment in Patients With Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest and safest topical anti-psoriatic treatments. However, despite explorative investigations, the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al, JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of dithranol in psoriasis.

Detailed Description
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Skins biopsies from psoriatic skin and blood samples will be taken before (day 0) and at several time points after start (day 4, week 2-3, and week 6-7) of dithranol therapy to be subjected to an explorative analysis (see outcome measures). A total of maximal 15 psoriasis patients will be enrolled. Normal lesion-adjacent skin from 10 patients undergoing surgery for non-inflammatory conditions will serve as control.

Official Title
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Study on the Therapeutic Mechanisms of Dithranol Treatment With Regard to Pro- and Contra-inflammatory Factors, microRNA as Well as Lymph and Blood Vessels in Patients With Chronic Plaque Psoriasis

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females over 18 years of age Clinical diagnosis of chronic plaque psoriasis Dithranol treatment scheduled Exclusion Criteria: Systemic anti-psoriatic therapy (DMARD, phototherapy and/or Biologics) within 4 weeks of study entry (start of dithranol treatment) Topical treatment with steroids and or vitamin D3 analogues within 2 weeks of study entry (start of dithranol treatment) Autoimmune disorders Poor general health status Intolerance of dithranol Pregnancy and lactation period

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis<br>Psoriasis patients treated with dithranol | |
| Non-Psoriasis<br>Non-Psoriasis patients undergoing surgery for skin lesions. Tumor-adjacent skin is collected for control purposes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood |  | day 0, 4, 14, 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MicroRNA expression in skin and blood |  | day 0, 4, 14, 42 | 
| Size and density of lymph and blood vessels in the skin |  | day 0, 4, 14, 42 | 
| Angiogenic factors and their receptors in the skin |  | day 0, 4, 14, 42 | 
| Inflammatory infiltrate in the skin and alterations of the epidermis |  | day 0, 4, 14, 42 | 
| Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes |  | day 0, 4, 14, 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dithranol, therapeutic mechanisms