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

NCT ID: NCT02752672

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Psoriasis

Keywords

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dithranol therapeutic mechanisms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriasis

Psoriasis patients treated with dithranol

No interventions assigned to this group

Non-Psoriasis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Peter Wolf, MD

Univ.Prof. Dr. Peter Wolf

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 33644099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32484435 (View on PubMed)

Other Identifiers

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A 23/15

Identifier Type: -

Identifier Source: org_study_id