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

Completed

• Conditions: Dystrophic Epidermolysis Bullosa
• Interventions: Other: Decriptive study of EDB

• Registration Number: NCT04757727
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EDB	Decriptive study of 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

Primary Outcome Measures

Name	Time	Method
Descriptve evaluation of the recruited population	12 months	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.; Descriptve evaluation of the recruited population Description of the anatomical and gynecological functional impairment of adult women with dystrophic epidermolysis bullosa.

Trial Locations

Locations (2)

CHU de NICE; 🇫🇷 Nice, France

Hôpital Saint Louis; 🇫🇷 Paris, France