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

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752672
• Other study ID #: A 23/15
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: October 26, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Woerthersee	Klagenfurt	Carinthia

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	State Hospital Klinikum Klagenfurt am Woerthersee

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood		day 0, 4, 14, 42
Secondary	MicroRNA expression in skin and blood		day 0, 4, 14, 42
Secondary	Size and density of lymph and blood vessels in the skin		day 0, 4, 14, 42
Secondary	Angiogenic factors and their receptors in the skin		day 0, 4, 14, 42
Secondary	Inflammatory infiltrate in the skin and alterations of the epidermis		day 0, 4, 14, 42
Secondary	Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes		day 0, 4, 14, 42