| NCT ID | NCT05954416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Inherited Epidermolysis Bullosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2018-03-07 |
| Primary Completion | 2027-03-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2018-03-07 with a primary completion date of 2027-03-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Christine BODEMER
PRINCIPAL INVESTIGATOR
INSERM UMR 1163
Frequently Asked Questions
Who can join the NCT05954416 clinical trial?
This trial is open to participants of all sexes, studying Inherited Epidermolysis Bullosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05954416 currently recruiting?
Yes, NCT05954416 is actively recruiting participants. Contact the research team at christine.bodemer@aphp.fr for enrollment information.
Where is the NCT05954416 trial being conducted?
This trial is being conducted at Bobigny, France, Bordeaux, France, Bordeaux, France, Créteil, France and 11 additional locations.
Who is sponsoring the NCT05954416 clinical trial?
NCT05954416 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Christine BODEMER at INSERM UMR 1163. The trial plans to enroll 900 participants.