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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04757727

Enrollment

Registered

2021-02-17

Start date

2021-01-01

Completion date

2021-12-30

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystrophic Epidermolysis Bullosa

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.

Interventions

OTHERDecriptive study of EDB

data on EDB will be register

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026