Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
PSODEEP2 Pilot Study on Koebner Induction in Psoriasis
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
Pilot Study on Koebner Induction in Patients With Plaque Psoriasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSODEEP2PIL
Brief Summary:
Patients n15 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 newslettermagazine 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-redcaporg 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 nitrilevinyl gloves and moved to D- squame Disc Carrier which are codedlabelled 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 08 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 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 newslettermagazine 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-redcaporg 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 nitrilevinyl gloves and moved to D- squame Disc Carrier which are codedlabelled 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 08 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None