Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

NCT ID: NCT04757727

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-30

Brief Summary

Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.

Conditions

Dystrophic Epidermolysis Bullosa

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EDB

Adult women (\> 18 years old) with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP

Decriptive study of EDB

Intervention Type: OTHER

data on EDB will be register

Interventions

Decriptive study of EDB

data on EDB will be register

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years old or older
• with hereditary dystrophic epidermolysis bullosa (dominant or recessive)
• followed at the Nice University Hospital or at the St Louis Hospital of the APHP.
• not opposed to participation after being informed of the study

Exclusion Criteria

• men
• age < 18years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de NICE

Nice, , France

Hôpital Saint Louis

Paris, , France

Countries

France

Other Identifiers

21dermato01

Identifier Type: -

Identifier Source: org_study_id