Psoriasis VulgarisPSODEEP2PILNCT06414382
PSODEEP2 Pilot Study on Koebner Induction in Psoriasis
A study testing Tape-stripping in people with Psoriasis Vulgaris and Koebner Phenomenon, run by Skane University Hospital.
Trial summary
Patients (n=15) with skin psoriasis, minimum age 18 years, without systemic immunomodulatory treatment will be subject to Koebner induction on arms and legs given that they have given written consent and that they have self-reported Koebner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris, Koebner Phenomenon
- What is being tested?
- Tape-stripping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2024to 7 Mar 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self reported Koebner
- Diagnosis of skin psoriasis
Who cannot join
- Systemic immunomodulatory treatment (including narrowband UVB)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study on Koebner Induction in Patients With Plaque Psoriasis
Patients (n=15) with skin psoriasis, minimum age 18 years, without systemic immunomodulatory treatment will be subject to Koebner induction on arms and legs given that they have given written consent and that they have self-reported Koebner.
Read the detailed description
PSODEEP2 PILOT STUDY
Study subject recruitation:
Individuals fulfilling inclusion and exclusion criteria will be identified and contacted from the PSODEEP1 study (ethical application2023-00571-02 and 2022-02835-01), advert in social media, advert in newsletter/magazine sent out by patients organizations (Ung med Psoriasis or Psoriasisförbundet) or through direct contact with patients visits in dermatology department (n = 15).
Inclusion criteria:
Psoriasis skin disease. Self-reported experience of Koebner phenomena. Age 18 years or older. Ability to comprehend study information. Signed and dated informed consent.
Exclusion criteria:
Ongoing or planned systemic immunomodulatory treatment. Ongoing or planned narrowband UVB or PUVA treatment. Lack of suitable non-lesional skin on proximal arm or thigh due to extensive psoriatic disease.
Intervention:
Non-lesional skin 22mm in diameter on proximal arm or thigh at least 5 cm from the closest psoriasis lesion will be identified and marked bilaterally using a surgical skin marker. The skin sites will be documented using digital photography and the photos will be stored in REDCap (project-redcap.org). Tape will be attached and removed from the skin 40 times at all 4 sites using D-squame 22mm sampling discs and D-squame pressure applicator. Tapes are to be removed using tweezers by research staff wearing nitrile/vinyl gloves and moved to D- squame Disc Carrier which are coded/labelled so that each sampling disc has a unique code. The codes are transferred to REDCap together with study subjects background information. Tapes are transferred to -70 storage in labelled cryotubes (stored one disc per tube) prior to proteomic analysis. Taped stripped skin on left arm and left thigh is then stimulated with microneedle device (Dermapen 4) set at 0,8 mm. Study subjects are asked to contact the research group if or when psoriasis develop at any of the four stimulated sites. Study subjects will be instructed to inspect skin once daily at a minimum. If uncertainty arises as to whether psoriasis has developed it will be possible to book an appointment for skin evaluation. If psoriasis develops a second appointment will be booked. At the second appointment all 4 locations will be documented using digital photography (and stored in REDCap). Locations will be re-sampled using 10 D- squame 22mm sampling discs per location. At locations showing signs of psoriasis development, induration, erythema and scaling will be assessed and recorded in REDCap (0- 4 points). In local anesthesia, a 4mm punch biopsy will be performed from developed psoriasis lesions (K+) (Koebner positive) and put in Eppendorf tube before being frozen on dry ice, labelled with unique code and transferred to - 70 freezer before further analysis. If no psoriasis develops then the study subjects will be booked for appointment 2 approximately day 21 after Koebner induction. For these subjects stratum corneum skin sampling will be performed at all four sites using 10 D-squame 2mm sampling discs transferred to D-squame Disc Carrier and then to cryotubes for storage at - 70 °C.
Bioanalysis:
For proteomic analysis, proteins will be lysed directly on the tape strips and prepared according to previously described protocol after which liquid chromatography-mass spectrometry will be performed (21).
Punch biopsies from developing or early psoriasis lesions will be analyzed accordingly to validate psoriasis development including histological assessment of signs of psoriasis (parakeratosis, psoriasiform hyperplasia, epidermal neutrophilic infiltration, dilated vessels in papillary dermis, loss of stratum granulosum). Additionally modern techniques analyzing the transcriptome, proteome and epigenome will be used to assess psoriasis development.
Study significance:
The PILOT study aims to answer research questions:
- Will the addition of micro-needling to tape-stripping increase Koebner reactivity in non-lesional psoriasis skin?
- Does Koebner-reactivity differ between proximal arm and proximal leg?
The answer to these questions are essential to determine the optimal intervention of the main study. The method and location that results in the higher proportion of Koebner positive reactions will be selected for the main study. It will also provide preliminary proteomic data which can facilitate a more accurate sample size calculation for main study.
- Conditions
- Psoriasis Vulgaris, Koebner Phenomenon
- Being tested
- Tape-stripping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tape-strippingOther
Also called Micro-needling
22mm tapes x 40 will be attached and removed to skin of all for limbs (tape stripping). On left arm and leg skin will also be subject to micro needling.
| Study group | Role | What they receive |
|---|---|---|
| Koebner induction | Experimental | Koebner will be induced on area 22mm in diameter on upper bilateral arms and anterior bilateral thighs. Receives: Other: Tape-stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Koebner Phenomena (K+)
Psoriasis lesion develops at site of provocation/induction
Measured: 7-21 days after induction
Negative Koebner Phenomena (K-)
No psoriasis lesion develops at site of provocation/induction
Measured: 21 days after induction
Secondary outcomes (1)
Stratum corneum proteomics
Mass spectrometry of stratum corneum at koebner induction sites
Measured: At baseline and at time of K+ assessment or day 21 if K-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start7 May 2024 (estimated)
- Primary completion7 Dec 2024 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Koebner phenomena will be induced using tape-stripping or tape-stripping and micro needling. Koebner development will be assessed.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Lund University
- Responsible party
- Principal investigator, Albert Duvetorp, Skane University Hospital
- Investigators
- Liv Eidsmo, Professor, Study director, Copenhagen University SIC, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414382
- Sponsor's protocol ID
- PSODEEP2PIL
- Acronym
- PSODEEP2PIL
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study necessary for selection of suitable method in subsequent follow up study. Data sharing outside research group has not been part of the ethical approval´s description of data handling. These two reasons are behind the "no".
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Koebner Induction in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06414382
- Acronym / sponsor ID
- PSODEEP2PIL / PSODEEP2PIL
- Conditions
- Psoriasis Vulgaris, Koebner Phenomenon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Lund University
- Study start
- 7 May 2024 (estimated)
- Primary completion
- 7 Dec 2024 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- 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.
Patients (n=15) with skin psoriasis, minimum age 18 years, without systemic immunomodulatory treatment will be subject to Koebner induction on arms and legs given that they have given written consent and that they have self-reported Koebner.
Detailed description
PSODEEP2 PILOT STUDY
Study subject recruitation:
Individuals fulfilling inclusion and exclusion criteria will be identified and contacted from the PSODEEP1 study (ethical application2023-00571-02 and 2022-02835-01), advert in social media, advert in newsletter/magazine sent out by patients organizations (Ung med Psoriasis or Psoriasisförbundet) or through direct contact with patients visits in dermatology department (n = 15).
Inclusion criteria:
Psoriasis skin disease. Self-reported experience of Koebner phenomena. Age 18 years or older. Ability to comprehend study information. Signed and dated informed consent.
Exclusion criteria:
Ongoing or planned systemic immunomodulatory treatment. Ongoing or planned narrowband UVB or PUVA treatment. Lack of suitable non-lesional skin on proximal arm or thigh due to extensive psoriatic disease.
Intervention:
Non-lesional skin 22mm in diameter on proximal arm or thigh at least 5 cm from the closest psoriasis lesion will be identified and marked bilaterally using a surgical skin marker. The skin sites will be documented using digital photography and the photos will be stored in REDCap (project-redcap.org). Tape will be attached and removed from the skin 40 times at all 4 sites using D-squame 22mm sampling discs and D-squame pressure applicator. Tapes are to be removed using tweezers by research staff wearing nitrile/vinyl gloves and moved to D- squame Disc Carrier which are coded/labelled so that each sampling disc has a unique code. The codes are transferred to REDCap together with study subjects background information. Tapes are transferred to -70 storage in labelled cryotubes (stored one disc per tube) prior to proteomic analysis. Taped stripped skin on left arm and left thigh is then stimulated with microneedle device (Dermapen 4) set at 0,8 mm. Study subjects are asked to contact the research group if or when psoriasis develop at any of the four stimulated sites. Study subjects will be instructed to inspect skin once daily at a minimum. If uncertainty arises as to whether psoriasis has developed it will be possible to book an appointment for skin evaluation. If psoriasis develops a second appointment will be booked. At the second appointment all 4 locations will be documented using digital photography (and stored in REDCap). Locations will be re-sampled using 10 D- squame 22mm sampling discs per location. At locations showing signs of psoriasis development, induration, erythema and scaling will be assessed and recorded in REDCap (0- 4 points). In local anesthesia, a 4mm punch biopsy will be performed from developed psoriasis lesions (K+) (Koebner positive) and put in Eppendorf tube before being frozen on dry ice, labelled with unique code and transferred to - 70 freezer before further analysis. If no psoriasis develops then the study subjects will be booked for appointment 2 approximately day 21 after Koebner induction. For these subjects stratum corneum skin sampling will be performed at all four sites using 10 D-squame 2mm sampling discs transferred to D-squame Disc Carrier and then to cryotubes for storage at - 70 °C.
Bioanalysis:
For proteomic analysis, proteins will be lysed directly on the tape strips and prepared according to previously described protocol after which liquid chromatography-mass spectrometry will be performed (21).
Punch biopsies from developing or early psoriasis lesions will be analyzed accordingly to validate psoriasis development including histological assessment of signs of psoriasis (parakeratosis, psoriasiform hyperplasia, epidermal neutrophilic infiltration, dilated vessels in papillary dermis, loss of stratum granulosum). Additionally modern techniques analyzing the transcriptome, proteome and epigenome will be used to assess psoriasis development.
Study significance:
The PILOT study aims to answer research questions:
- Will the addition of micro-needling to tape-stripping increase Koebner reactivity in non-lesional psoriasis skin?
- Does Koebner-reactivity differ between proximal arm and proximal leg?
The answer to these questions are essential to determine the optimal intervention of the main study. The method and location that results in the higher proportion of Koebner positive reactions will be selected for the main study. It will also provide preliminary proteomic data which can facilitate a more accurate sample size calculation for main study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Koebner phenomena will be induced using tape-stripping or tape-stripping and micro needling. Koebner development will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Koebner induction | Experimental | Other: Tape-strippingKoebner will be induced on area 22mm in diameter on upper bilateral arms and anterior bilateral thighs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self reported Koebner
- Diagnosis of skin psoriasis
Key exclusion criteria (1 listed)
- Systemic immunomodulatory treatment (including narrowband UVB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tape-strippingAlso: Micro-needling22mm tapes x 40 will be attached and removed to skin of all for limbs (tape stripping). On left arm and leg skin will also be subject to micro needling. | Other | Koebner induction |
Primary outcome
Positive Koebner Phenomena (K+)
Time frame: 7-21 days after induction
Psoriasis lesion develops at site of provocation/induction
Negative Koebner Phenomena (K-)
Time frame: 21 days after induction
No psoriasis lesion develops at site of provocation/induction
1 secondary outcome
Stratum corneum proteomics
Time frame: At baseline and at time of K+ assessment or day 21 if K-
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. This is a pilot study necessary for selection of suitable method in subsequent follow up study. Data sharing outside research group has not been part of the ethical approval´s description of data handling. These two reasons are behind the "no".
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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.
Liv Eidsmo, Professor study director
Copenhagen University SIC, Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Tape-stripping in people with Psoriasis Vulgaris and Koebner Phenomenon, run by Skane University Hospital.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Duvetorp, PhD MD (+460736166946, albert.duvetorp@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Koebner Phenomena (K+) (time frame: 7-21 days after induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.