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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02752672

Enrollment

Registered

2016-04-27

Start date

2016-03-31

Completion date

2016-11-30

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

dithranol, therapeutic mechanisms

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Austria

Outcome results