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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2016

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.

Arms, Groups and Cohorts

  • Psoriasis
    • Psoriasis patients treated with dithranol
  • Non-Psoriasis
    • Non-Psoriasis patients undergoing surgery for skin lesions. Tumor-adjacent skin is collected for control purposes.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Graz
  • Collaborator
    • Klinikum Klagenfurt am Wörthersee
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Wolf, MD, Univ.Prof. Dr. Peter Wolf – Medical University of Graz

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.