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Completed

NCT Number: NCT02808559

PASIMAT: Automatic Measure of PASI

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bodystudio ATBM (Automatic Total Body Mapping)

Device

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 outcomes

  1. Psoriasis Area and Severity Index

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Fotofinder
  • Pfizer

Registry information

Official study title

PASIMAT: Automatic Measure of PASI by Skin Imaging

Acronym: PASIMAT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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