PHOTODERM: Interest of Photographs by Smartphone in Dermatology

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03493724

Collaborator

(none)

205

Enrollment

Location

6.6

Anticipated Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology

Condition or Disease	Intervention/Treatment	Phase
Dermatitis	Other: telemedecine

Detailed Description

The study is conducted in the dermatology department, for a maximum duration of 6 months. We include patients who require dermatological advice and for whom their doctor sends us photographs.

Doctors contact us by telephone, describe the symptoms and send photographs according to the secure procedure.

Patients are admitted for consultation and the diagnosis by photography is compared with the clinical diagnosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

205 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Interest of the Photographs by Smartphone During the Requests of Opinion Specialized in the Department of Dermatology of the CHRU of Nancy

Actual Study Start Date :

Feb 13, 2018

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Outcome Measures

Primary Outcome Measures

sensitivity, specificity, positive and negative predictive values globally [through study completion, an average 6 months]
evaluation of the diagnostic performance of the test
sensitivity, specificity, positive and negative predictive values stratified [through study completion, an average 6 months]
stratified on the families of pathologies : infectious pathology, inflammatory dermatosis, allergology, wound, oncology

Secondary Outcome Measures

Calculation of Cohen's kappa concordance between dermatologists [through study completion, an average 6 months]
assessment of interobserver diagnostic agreement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For which our fellow doctors ask a dermatological opinion for diagnostic purposes, after clinical examination of the patient, in an emergency
After obtaining the oral consent by the requesting doctor then informing and signing a non-opposition form during the consultation at the University Hospital of Nancy
Affiliation to a social protection
Doctors must have signed and sent back an ethical charter, where they undertake to send the image via MSsante, then to erase the image of the smartphone

Exclusion Criteria:

Patients under the protection of justice, tutorship or curatorship
Doctors : lack of smartphone powerful enough to offer a quality image

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Nancy, hopitaux de Brabois	Nancy	Vandoeuvre Les Nancy	France	54000

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT03493724

Other Study ID Numbers:

2017-A02607-46

First Posted:

Apr 10, 2018

Last Update Posted:

Apr 10, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Additional relevant MeSH terms:

Dermatitis

Study Results

No Results Posted as of Apr 10, 2018