FARD (RaDiCo Cohort) (RaDiCo-FARD) (FARD)

February 10, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

National Cohort for Evaluation of the Burden of Rare Skin Diseases

The goal of this observational study is to conduct a prospective assessment of the individual Burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families.

Two types of indicators will be used to reach this objective :

  1. an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. The burden questionnaire should be used by patients and/or their family themselves in self-assessment.
  2. a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bobigny, France
        • Not yet recruiting
        • Hopital Avicenne
        • Contact:
          • Catherine Prost
      • Bordeaux, France
        • Not yet recruiting
        • Hôpital des Enfants - Groupe Hospitalier Pellegrin
        • Contact:
          • Marie-Sylvie DOUTRE
      • Créteil, France
        • Not yet recruiting
        • Hôpital Henri-Mondor
        • Contact:
          • Pierre WOLKENSTEIN
      • Dijon, France
        • Not yet recruiting
        • Hôpital François Mitterrand
        • Contact:
          • Pierre VABRE
      • Limoges, France
        • Not yet recruiting
        • Hopital Dupuytren
        • Contact:
          • Christophe Bedane
      • Marseille, France
        • Not yet recruiting
        • Hopital De La Timone
        • Contact:
          • Marie-Aleth Richard
      • Montpellier, France
        • Not yet recruiting
        • Hopital Saint-Eloi
        • Contact:
          • Didier BESSIS
      • Nice, France
        • Recruiting
        • Hôpital l'Archet
        • Contact:
          • Christine CHIAVERINI
      • Paris, France
        • Recruiting
        • Hôpital Necker-Enfants Malades
        • Contact:
          • Christine BODEMER
      • Paris, France
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Emmanuelle BOURRAT
      • Reims, France
        • Not yet recruiting
        • Hôpital Robert-Debré
        • Contact:
          • Philippe BERNARD
      • Rouen, France
        • Recruiting
        • Hôpital Charles Nicolle
        • Contact:
          • Pascal JOLY
      • Toulouse, France
        • Recruiting
        • Hôpital Larrey
        • Contact:
          • Juliette MAZEREEUW-HAUTIER
      • Tours, France
        • Recruiting
        • Hôpital Trousseau
        • Contact:
          • Annabel MARUANI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study concerns patients affected by one the 9 following rare skin diseases: Inherited epidermolysis bullosa, ichthyosis, ectodermal dysplasia, Incontinentia Pigmenti, neurofibromatosis type 1, albinism, pemphigus, mucous membrane pemphigoid, and palmoplantar keratoderma recruited and followed in a reference/competence centre of the healthcare network of rare dermatologic diseases, FIMARAD.

Description

Inclusion criteria :

  • adults or children with a confirmed diagnosis of one of the 9 following rare skin disease: Inherited epidermolysis bullosa, Ichthyosis, Ectodermal dysplasia, Incontinetia Pigmenti, Neurofibromatosis type 1, Albinism, Pemphigus, Mucous membrane pemphigoid or Palmoplantar keratoderma.
  • prevalent or incident and followed in one the reference/competence centers of the FIMARAD healthcare network,
  • able to understand a survey (for child, survey should be understood by parents),
  • having given their signed consent to participate to the cohort RaDiCo-FARD (parents' consent for child).

Non-inclusion criteria :

  • Patients, for whom regular care follow-up is not feasible with the FIMARAD healthcare network sites,
  • Unconfirmed diagnosis (according to criteria for each disease),
  • Patients (and/or parents) not able to understand a survey
  • Patients (and/or parents) not having given their signed consent to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual burden score for each selected rare disease
Time Frame: Through study completion, an average of 5 years
Before 16 years old, we will focus on the burden of families. After 16 years old, the patient's parent will continue to answer to the family Burden questionnaire and the patient will start to answer to the adult's Burden questionnaire.
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of calculated scores based on widely used survey completed by patients
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Description of calculated scores based on widely used survey completed by parents
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Description of variations of quality-of-life scores.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Validation of the clinical severity score for disease which have none at the beginning of the study and description of clinical severity score.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Descriptive analysis of the socio-economic Burden.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Descriptive analysis of the Individual Health Care Cost.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Search for association between individual burden score and clinical severity of the disease.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Christine BODEMER, INSERM UMR 1163

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2018

Primary Completion (Estimated)

March 7, 2027

Study Completion (Estimated)

March 7, 2027

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16-78

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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