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NCT Number: NCT02752672

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, 9020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood

    Time frame: day 0, 4, 14, 42

Secondary outcomes

  1. MicroRNA expression in skin and blood

    Time frame: day 0, 4, 14, 42

  2. Size and density of lymph and blood vessels in the skin

    Time frame: day 0, 4, 14, 42

  3. Angiogenic factors and their receptors in the skin

    Time frame: day 0, 4, 14, 42

  4. Inflammatory infiltrate in the skin and alterations of the epidermis

    Time frame: day 0, 4, 14, 42

  5. Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes

    Time frame: day 0, 4, 14, 42

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Klinikum Klagenfurt am Wörthersee

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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