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

NCT02752672 | Completed

• 1 other identifier: A 23/15
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

dithranol; therapeutic mechanisms

Outcome Measures

Primary Outcomes (1)

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

  day 0, 4, 14, 42

Secondary Outcomes (5)

• 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

Study Arms (2)

Psoriasis

Psoriasis patients treated with dithranol

Non-Psoriasis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Males and females over 18 years of age
• Clinical diagnosis of chronic plaque psoriasis
• Dithranol treatment scheduled

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Klinikum Klagenfurt am Wörthersee: collaborator

Study Sites (1)

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, 9020, Austria

Location

Related Publications (2)

• Graier T, Golob-Schwarzl N, Weger W, Benezeder T, Painsi C, Salmhofer W, Wolf P. Furin Expression in Patients With Psoriasis-A Patient Cohort Endangered to SARS-COV2? Front Med (Lausanne). 2021 Feb 10;8:624462. doi: 10.3389/fmed.2021.624462. eCollection 2021.

  PMID: 33644099 DERIVED

• Benezeder T, Painsi C, Patra V, Dey S, Holcmann M, Lange-Asschenfeldt B, Sibilia M, Wolf P. Dithranol targets keratinocytes, their crosstalk with neutrophils and inhibits the IL-36 inflammatory loop in psoriasis. Elife. 2020 Jun 2;9:e56991. doi: 10.7554/eLife.56991.

  PMID: 32484435 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Skin Biopsies

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof. Dr. Peter Wolf

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 27, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

AU (1)