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

NCT04757727 | Completed

• 1 other identifier: 21dermato01
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Descriptve evaluation of the recruited population

  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.

  12 months

Study Arms (1)

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

Other: Decriptive study of EDB

Interventions

Decriptive study of EDB OTHER

data on EDB will be register

EDB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• men
• age \< 18years old

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de NICE

Nice, 06200, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)