PsoriasisNCT02752672
Study on the Therapeutic Mechanisms of Dithranol Treatment in Patients With Chronic Plaque Psoriasis
An observational study of Psoriasis, run by Medical University of Graz at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 27 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Males and females over 18 years of age
- Clinical diagnosis of chronic plaque psoriasis
- Dithranol treatment scheduled
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- dithranol, therapeutic mechanisms
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Psoriasis patients treated with dithranol | |
| Non-Psoriasis | Non-Psoriasis patients undergoing surgery for skin lesions. Tumor-adjacent skin is collected for control purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood
Measured: day 0, 4, 14, 42
Secondary outcomes (5)
MicroRNA expression in skin and blood
Measured: day 0, 4, 14, 42
Size and density of lymph and blood vessels in the skin
Measured: day 0, 4, 14, 42
Angiogenic factors and their receptors in the skin
Measured: day 0, 4, 14, 42
Inflammatory infiltrate in the skin and alterations of the epidermis
Measured: day 0, 4, 14, 42
Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes
Measured: day 0, 4, 14, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Klagenfurt am Wörthersee
- Responsible party
- Principal investigator, Peter Wolf, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752672
- Sponsor's protocol ID
- A 23/15
- Status last verified
- Oct 2017
- First submitted
- 22 Apr 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33644099Benezeder 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.
PubMed 32484435
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02752672
- Acronym / sponsor ID
- A 23/15
- Conditions
- Psoriasis
- Keywords
- dithranol, therapeutic mechanisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Klinikum Klagenfurt am Wörthersee
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | –Psoriasis patients treated with dithranol |
| Non-Psoriasis | – | –Non-Psoriasis patients undergoing surgery for skin lesions. Tumor-adjacent skin is collected for control purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Males and females over 18 years of age
- Clinical diagnosis of chronic plaque psoriasis
- Dithranol treatment scheduled
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood
Time frame: day 0, 4, 14, 42
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 33644099Graier 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.
- Derived from this study: PubMed 32484435Benezeder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood (time frame: day 0, 4, 14, 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.