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NCT04217538 Clinical Trial

Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

Epidermolysis Bullosa Clinical Trial

Official title:
Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa That Come for Their Annual/Biannual Check up at This Medical Rare Disease Reference Centers (MRDRC) of This Disease in France and Belgium

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04217538
Other study ID # 19-ODONTO-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2017
Est. completion date December 11, 2019

Study information
Verified date December 2019
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hereditary Epidermolysis Bullosa (EBH) are rare dermatologic diseases characterized by cutaneous and mucosa fragility. Oral manifestations of few small cohort have been published. The main objective of this multicentric cohort study first in Europe was to report the oral status of these patients that were consulted in the MRDRC of this disease in Nice (France), Toulouse (France) and Louvain (Belgium). Then a correlation between the oral characteristics and the EBH type will be made, in order to facilitate the management of patient care and the prevention program that can be established to improve their oral health.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date December 11, 2019
Est. primary completion date December 11, 2019
Accepts healthy volunteers
Gender All
Age group 7 Months to 78 Years
Eligibility Inclusion Criteria:

- patient with EBH

- patient consent for examination and use the clinical data for publication purpose

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• clinical exam
clinical oral examination

Locations
Country Name City State
France Nice Hospital Nice
France Toulouse University Toucy

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 Dental structural abnormalities and/or caries number of defect /dental caries dor each toth 1 day
Secondary gingival biotype clinical observation of gingiva (thin or thick) 1 day
Secondary gingival status observation and classification of the gingiva (healthy, inflammed or hyperplastic) 1 day
Secondary plaque and gingival index registration of plaque and gingival index according to the Loë and Silness method 1 day
Secondary oral lesion number and localisation of the blister/scars/flanges scars on a sketch of a mouth 1 day
See also
  Status Clinical Trial Phase
Completed NCT00380640 - The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa Phase 2
Completed NCT00004761 - Establishment of the National Epidermolysis Bullosa Registry N/A
Completed NCT01263379 - Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Completed NCT01716169 - Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care N/A
Withdrawn NCT01454687 - Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes N/A
Completed NCT00014729 - Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Phase 1
Recruiting NCT05838092 - Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) Phase 3
Recruiting NCT03269474 - Computational Drug Repurposing for All EBS Cases
Completed NCT03068780 - Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa Phase 3
Terminated NCT02090283 - Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 2
Completed NCT02582775 - MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Phase 2
Recruiting NCT04213703 - A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Completed NCT02384460 - ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 3
Terminated NCT02670330 - Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Phase 3
Terminated NCT01619670 - A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Phase 4
Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
Completed NCT02014376 - Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Phase 2
Completed NCT03942250 - Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients N/A
Completed NCT01033552 - Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs Phase 1/Phase 2
Completed NCT04227106 - Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 3