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RecruitingNCT05954416FARDUpdated Feb 12, 2026

FARD (RaDiCo Cohort) (RaDiCo-FARD)

An observational study in Inherited Epidermolysis Bullosa, Ichthyosis and Ectodermal Dysplasia, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 15 sites in France. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

From the registry’s dates

  • Started Mar 2018; still recruiting 8 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
900
Sex
All
01

Study summary

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.
02

Conditions studied

  • Inherited Epidermolysis Bullosa
  • Ichthyosis
  • Ectodermal Dysplasia
  • Incontinentia Pigmenti
  • Neurofibromatosis Type 1
  • Albinism
  • Pemphigus
  • Mucous Membrane Pemphigoid
  • Palmoplantar Keratoderma
03

In context

Ichthyosis

33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.

Browse Ichthyosis studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
900 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Individual burden score for each selected rare disease

    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.

    Time frame: Through study completion, an average of 5 years

Secondary outcomes

  1. Description of calculated scores based on widely used survey completed by patients

    Time frame: Through study completion, an average of 5 years

  2. Description of calculated scores based on widely used survey completed by parents

    Time frame: Through study completion, an average of 5 years

  3. Description of variations of quality-of-life scores.

    Time frame: Through study completion, an average of 5 years

  4. 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

  5. Descriptive analysis of the socio-economic Burden.

    Time frame: Through study completion, an average of 5 years

  6. Descriptive analysis of the Individual Health Care Cost.

    Time frame: Through study completion, an average of 5 years

  7. Search for association between individual burden score and clinical severity of the disease.

    Time frame: Through study completion, an average of 5 years

07

Study locations

6 of 15 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for Mar 2027, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2023
First posted
Jul 20, 2023
StartActual
Mar 7, 2018
Primary completionEst.
Mar 7, 2027
CompletionEst.
Mar 7, 2027
Last update
Feb 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05954416
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Mar 7, 2018
Primary completion
Mar 7, 2027 (estimated)
Completion
Mar 7, 2027 (estimated)
Last update
Feb 12, 2026

Study contacts

Christine BODEMER
Contact
christine.bodemer@aphp.fr
+ 33 1 44 49 46 72
Christine BODEMER
principal investigator · INSERM UMR 1163

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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