PSODEEP2 Pilot Study on Koebner Induction in Psoriasis

NCT06414382 | Not Yet Recruiting

• 1 other identifier: PSODEEP2PIL
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis Vulgaris; Koebner Phenomenon

Outcome Measures

Primary Outcomes (2)

• Positive Koebner Phenomena (K+)

  Psoriasis lesion develops at site of provocation/induction

  7-21 days after induction

• Negative Koebner Phenomena (K-)

  No psoriasis lesion develops at site of provocation/induction

  21 days after induction

Secondary Outcomes (1)

• Stratum corneum proteomics

  At baseline and at time of K+ assessment or day 21 if K-

Study Arms (1)

Koebner induction

EXPERIMENTAL

Koebner will be induced on area 22mm in diameter on upper bilateral arms and anterior bilateral thighs.

Other: Tape-stripping

Interventions

Tape-stripping OTHER

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.

Also known as: Micro-needling

Koebner induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self reported Koebner
• Diagnosis of skin psoriasis

You may not qualify if:

• Systemic immunomodulatory treatment (including narrowband UVB)

Sponsors & Collaborators

• Skane University Hospital: lead
• University of Copenhagen: collaborator
• Lund University: collaborator

Study Officials

• Liv Eidsmo, Professor

  Copenhagen University SIC, Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Albert Duvetorp, PhD MD

CONTACT

+460736166946; albert.duvetorp@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Koebner phenomena will be induced using tape-stripping or tape-stripping and micro needling. Koebner development will be assessed.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: May 7, 2024
• Primary Completion: December 7, 2024
• Study Completion: March 7, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share