- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06414382
PSODEEP2 Pilot Study on Koebner Induction in Psoriasis (PSODEEP2PIL)
Pilot Study on Koebner Induction in Patients With Plaque Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Albert Duvetorp, PhD MD
- Phone Number: +460736166946
- Email: albert.duvetorp@skane.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self reported Koebner
- Diagnosis of skin psoriasis
Exclusion Criteria:
- Systemic immunomodulatory treatment (including narrowband UVB)
Study Plan
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: Koebner induction
Koebner will be induced on area 22mm in diameter on upper bilateral arms and anterior bilateral thighs.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Koebner Phenomena (K+)
Time Frame: 7-21 days after induction
|
Psoriasis lesion develops at site of provocation/induction
|
7-21 days after induction
|
Negative Koebner Phenomena (K-)
Time Frame: 21 days after induction
|
No psoriasis lesion develops at site of provocation/induction
|
21 days after induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stratum corneum proteomics
Time Frame: At baseline and at time of K+ assessment or day 21 if K-
|
Mass spectrometry of stratum corneum at koebner induction sites
|
At baseline and at time of K+ assessment or day 21 if K-
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Liv Eidsmo, Professor, Copenhagen University SIC, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSODEEP2PIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
University of California, San FranciscoTerminatedPlaque Psoriasis | Psoriasis VulgarisUnited States
-
University Hospital, GhentBelgium Health Care Knowledge CentreNot yet recruiting
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
Clinical Trials on Tape-stripping
-
Marie-Charlotte BrüggenNot yet recruitingPsoriasis | Lichen Planus | Kobner Phenomenon
-
Dr. Robert BissonnetteRecruiting
-
University of California, DavisTerminated
-
University of MichiganAbbVieCompleted
-
National Jewish HealthMedImmune LLCUnknownAtopic DermatitisUnited States
-
University of ViennaMedical University of ViennaCompletedSkin Physiology | Dermal Administration | EmulsionsAustria
-
University of RochesterRecruiting
-
Memorial Sloan Kettering Cancer CenterRecruitingBasal Cell CarcinomaUnited States
-
National Jewish HealthWithdrawnEczema | Atopic Dermatitis | Food AllergyUnited States
-
National Jewish HealthSuspendedFood Allergy in ChildrenUnited States