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
About this trial
This is an interventional diagnostic trial for Psoriasis
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
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
NCT ID
NCT02808559
First Posted
June 15, 2016
Last Updated
June 17, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Pfizer, Fotofinder
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
Learn more about this trial
PASIMAT: Automatic Measure of PASI
We'll reach out to this number within 24 hrs