Epidermolysis BullosaNCT04217538
Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
An observational study of Epidermolysis Bullosa, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 7 months to 78 years
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- clinical exam
- Type of treatment
- Pill or oral medicine
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jan 2017to 11 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 months to 78 years
- All sexes
- Child, Adult, Older adult
Study population: All patients with EBH are recruted from the 2 MRDRC of the disease in France and the one of Belgium, the dental visit was/is organized for each visit/follow up of the patient in the center (annual or bianual visit)
Who may be able to join
- patient with EBH
- patient consent for examination and use the clinical data for publication purpose
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Epidermolysis Bullosa
- Being tested
- clinical exam
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examOther
clinical oral examination
| Study group | Role | What they receive |
|---|---|---|
| EBH | Not described Receives: Other: clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental structural abnormalities and/or caries
number of defect /dental caries dor each toth
Measured: 1 day
Secondary outcomes (4)
gingival biotype
clinical observation of gingiva (thin or thick)
Measured: 1 day
gingival status
observation and classification of the gingiva (healthy, inflammed or hyperplastic)
Measured: 1 day
plaque and gingival index
registration of plaque and gingival index according to the Loë and Silness method
Measured: 1 day
oral lesion
number and localisation of the blister/scars/flanges scars on a sketch of a mouth
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start4 Jan 2017
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217538
- Sponsor's protocol ID
- 19-ODONTO-01
- Status last verified
- Dec 2019
- First submitted
- 31 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04217538
- Acronym / sponsor ID
- 19-ODONTO-01
- Conditions
- Epidermolysis Bullosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBH | – | Other: clinical exam |
Who may qualify
- Ages
- 7 months to 78 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with EBH are recruted from the 2 MRDRC of the disease in France and the one of Belgium, the dental visit was/is organized for each visit/follow up of the patient in the center (annual or bianual visit)
Key inclusion criteria (2 listed)
- patient with EBH
- patient consent for examination and use the clinical data for publication purpose
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical examclinical oral examination | Other | EBH |
Primary outcome
Dental structural abnormalities and/or caries
Time frame: 1 day
number of defect /dental caries dor each toth
4 secondary outcomes
gingival biotype
Time frame: 1 day
gingival status
Time frame: 1 day
plaque and gingival index
Time frame: 1 day
oral lesion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermolysis Bullosa, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental structural abnormalities and/or caries (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.