- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021405
Koebner's Phenomenon in Psoriasis and Lichen Planus (RENBOEK)
March 16, 2026 updated by: Marie-Charlotte Brüggen
A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus
Psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g.
tight clothing).
The investigators would like to investigate this phenomenon in more detail in this study.
For this purpose, the skin is specifically irritated at a small and cosmetically favorable site by tearing off scotch tape or rubbing with a wooden spatula.
In order to be able to examine the inflammatory processes caused by the irritation more closely, a small skin sample and a skin swab are taken from the irritated area.
This skin sample and the swab are repeated after three and fourteen days.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen planus) or no skin disease (group healthy controls)
- Subject is capable of giving informed consent
- Signed informed consent
Exclusion Criteria:
- Use of systemic immunosuppressive/immunmodulating agents in the last three months
- Use of topical anti-inflammatory treatment in the last 7 days in the area of sampling.
- Phototherapy in the last 4 weeks
- Active or recurrent serious bacterial, fungal or viral infection at the time of enrollment by patient history, including patients with Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
- Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tape stripping
|
a small area of skin will be tape-stripped with adhesive tape for up to 40 times and/or rubbed with a wooden spatula until the skin shows a slight erythema
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
Time Frame: Day 0, Day 3 (optional), Day 14 (optional)
|
Transcriptomic profile at all timepoints (reads per 55µm diameter dot)
|
Day 0, Day 3 (optional), Day 14 (optional)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon
Time Frame: Day 0, Day 3 (optional), Day 14 (optional)
|
Olink multiplex proteomics analysis at all timepoints
|
Day 0, Day 3 (optional), Day 14 (optional)
|
|
Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon
Time Frame: Day 0, Day 3 (optional), Day 14 (optional)
|
Imaging mass cytometry (skin biopsies) at all timepoints
|
Day 0, Day 3 (optional), Day 14 (optional)
|
|
Characterization of skin mikrobiome
Time Frame: Day 0, Day 3, Day 14
|
Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA
|
Day 0, Day 3, Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Charlotte Brüggen, MD PhD, University of Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
September 20, 2025
Study Completion (Actual)
September 20, 2025
Study Registration Dates
First Submitted
August 11, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
September 1, 2023
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-00427
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.