Clinical trial NCT02752672: Study on the Therapeutic Mechanisms of Dithranol Treatment in Patients With Chronic Plaque Psoriasis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: dithranol
therapeutic mechanisms
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Klinikum Klagenfurt am Wörthersee
First posted: 2016-04-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood
timeFrame: day 0, 4, 14, 42
Secondary outcomes:
measure: MicroRNA expression in skin and blood
timeFrame: day 0, 4, 14, 42
measure: Size and density of lymph and blood vessels in the skin
timeFrame: day 0, 4, 14, 42
measure: Angiogenic factors and their receptors in the skin
timeFrame: day 0, 4, 14, 42
measure: Inflammatory infiltrate in the skin and alterations of the epidermis
timeFrame: day 0, 4, 14, 42
measure: Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes
timeFrame: day 0, 4, 14, 42
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Woerthersee
state: Carinthia
Study officials:
References:
citation: 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.
citation: 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.