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PASIMAT: Automatic Measure of PASI (PASIMAT)

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bodystudio ATBM (Automatic Total Body Mapping)
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >= 18 years old
  • Subject is affiliated to a National Health System at screening visit
  • Understand and sign an Informed Consent Form (ICF) at screening, prior to any investigational procedures being performed.
  • Patient with moderate to severe Plaque psoriasis.
  • The patient is willing and able to be evaluated by the Bodystudio ATBM: 3 minutes for a young patient and until 7 minutes for an oldest.
  • The patient is able to staying up during all the total body mapping procedure

Exclusion Criteria:

  • The subject is vulnerable (such as deprived from freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
  • Pregnant woman or who are breast-feeding
  • Patient with tattoos that could influence the PASI assessment.
  • Patient with skin type (phototype) V or IV according to Fitzpatrick classification
  • Male patients with exceeding facial or skin hair that could influence the automatic PASI assessment.
  • Patients with exceeding varicose veins.
  • Patients with sun burn

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bodystudio ATBM

    Arm Description

    The PASI of the patients will be evaluated by two dermatologists then by the bodystudio ATBMs.

    Outcomes

    Primary Outcome Measures

    Psoriasis Area and Severity Index

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2016
    Last Updated
    June 17, 2016
    Sponsor
    Centre Hospitalier Universitaire de Nice
    Collaborators
    Pfizer, Fotofinder
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02808559
    Brief Title
    PASIMAT: Automatic Measure of PASI
    Acronym
    PASIMAT
    Official Title
    PASIMAT: Automatic Measure of PASI by Skin Imaging
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice
    Collaborators
    Pfizer, Fotofinder

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. PASI (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis assessment. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes.The primary objective of this study would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of patients with psoriasis human body in a few minutes
    Detailed Description
    Psoriasis is a chronic inflammatory skin condition resulting in a significant impact on patients' quality of life. To quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. PASI (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis assessment. However the measure of the PASI score is very complex. Given this complexity, the PASI is influenced by inter and intra-rater variation. In addition the PASI assessment process is time consuming. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes. The mapping of the entire body is automatically done by the use of a digital camera performing 20 pictures of the patient with 8 successive positions. The system is coupled to a software of automatic analysis of these pictures for the measure of the PASI score. The primary objective of this study would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of patients with psoriasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bodystudio ATBM
    Arm Type
    Experimental
    Arm Description
    The PASI of the patients will be evaluated by two dermatologists then by the bodystudio ATBMs.
    Intervention Type
    Device
    Intervention Name(s)
    Bodystudio ATBM (Automatic Total Body Mapping)
    Intervention Description
    The mapping of the entire body is automatically done using a high-resolution apparatus (20 photographs of the patient in 8 positions (face, back, lateral left and right, specific extremities) The photographs will be done with a standardized procedure established by FotoFinder. Every lesion is completely evaluated and the PASI score can be calculated.
    Primary Outcome Measure Information:
    Title
    Psoriasis Area and Severity Index
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >= 18 years old Subject is affiliated to a National Health System at screening visit Understand and sign an Informed Consent Form (ICF) at screening, prior to any investigational procedures being performed. Patient with moderate to severe Plaque psoriasis. The patient is willing and able to be evaluated by the Bodystudio ATBM: 3 minutes for a young patient and until 7 minutes for an oldest. The patient is able to staying up during all the total body mapping procedure Exclusion Criteria: The subject is vulnerable (such as deprived from freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP). Pregnant woman or who are breast-feeding Patient with tattoos that could influence the PASI assessment. Patient with skin type (phototype) V or IV according to Fitzpatrick classification Male patients with exceeding facial or skin hair that could influence the automatic PASI assessment. Patients with exceeding varicose veins. Patients with sun burn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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