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

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757727
• Other study ID #: 21dermato01
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christine CHIAVERINI
• Phone: +33492036107
• Email: chiaverini.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystrophic Epidermolysis Bullosa
• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Intervention

Other:
• Decriptive study of EDB
data on EDB will be register

Locations

Country	Name	City	State
France	CHU de NICE	Nice
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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