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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04757727
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Anticipated Duration (Months): 8.9
• Patients Per Site: 15
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dystrophic Epidermolysis Bullosa	Other: Decriptive study of EDB

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; data on EDB will be register

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de NICE	Nice		France	06200
2	Hôpital Saint Louis	Paris		France	75010

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT04757727
• Other Study ID Numbers: 21dermato01
• First Posted: Feb 17, 2021
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica

Study Results

No Results Posted as of Feb 17, 2021