PASIMAT: Automatic Measure of PASI

NCT02808559 | Completed DMC

• 1 other identifier: 14-AOI-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index

  one day

Study Arms (1)

Bodystudio ATBM

EXPERIMENTAL

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

Device: Bodystudio ATBM (Automatic Total Body Mapping)

Interventions

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.

Bodystudio ATBM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Pfizer: collaborator
• Fotofinder: collaborator

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 21, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 21, 2016

Record last verified: 2016-06