Epidermolysis BullosaEBROPINCT03730584
Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
A study testing Ropivacaine and Blood test in people with Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- Ropivacaine and Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 28 Nov 2019
- Phase
- Interventional
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa,
- Presenting pain at the entrance of the bath with an average of EVA or FLACC greater than 4/10 the week before the inclusion
- Usually requiring premedication with weak or strong opioid
- Parental consent if minor or patient consent
- Affiliated with Social Security
Who cannot join
- Patient with a known allergy to ROPIVACAINE or other local anesthetics with amide binding or one of the excipients mentioned in the SPC
- Severe renal insufficiency defined by DFG below 29ml / min
- Moderate to severe hepatic insufficiency defined by a Child-Pugh B or C score and AST or ALAT greater than 3 times normal
- Moderate to severe cardiac failure defined by FEGV less than 45% and/or NYHA class II to IV
- Hypovolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa.
Read the detailed description
This clinical trial aims to determine the efficacy on pain of local application of ROPIVACAINE 0.2% on cutaneous lesions related to Epidermolysis Bullosa during dressing change, associated with the standard premedication.
Patients will be hospitalized and will have several baths. The first bath will be done according to usual protocol (usual premedication 1h before the bath). Pain measurements (Visual analog scale or FLACC) will be done at the entry into the water, in the middle of bath and at the time of the dressing change.
The following baths will be done using local application of Ropivacaine 15 minutes before entering into the water on lesions identified by the patients as the most painful lesions due to Epidermolysis Bullosa.
A blood test will be done during the first use of Ropivacaine to determine plasmatic level of Ropivacaine.
After 3 baths in the dermatology unit, patients will continue such bath at home, every 48h during 15 days.
- Conditions
- Epidermolysis Bullosa
- Being tested
- Ropivacaine, Blood test
- Keywords
- Hereditary Epidermolysis Bullosa, pain, bath, dressing change, Ropivacaine, topical application
- Medical subject headings
- Epidermolysis Bullosa, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ampoules of ROPIVACAINE 2mg / ml will be used by local cutaneous application in soft application with device of "hand shower" on the painful wounds without exceeding the dose of 1mg / kg per bath.
Blood testBiological
Blood test during the first bath with Ropivacaine for Titration of Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Patient with Hereditary Epidermolysis Bullosa | Experimental | Not described Receives: Drug: Ropivacaine; Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on pain of Ropivacaine at the bath entrance
Evaluation performed by child with a Visual Analog Scale (VAS) or by parents with the Face Legs Activity Cry Consolability questionary (FLACC) - defined by a 2 points loss between day 1 and day 5
Measured: Day 5
Secondary outcomes (7)
Efficacy on pain of Ropivacaine at the time of dressing change
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing - defined by a 2 points loss between day 1 and day 5
Measured: Day 5
Efficacy on pain of Ropivacaine at home at the time of dressing change
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing
Measured: Day 21
Efficacy on pain of Ropivacaine at home at bath entrance
Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance
Measured: Day 21
Measurement of Local or systemic side effects
Evaluation of tolerance of Ropivacaine
Measured: Day 5
Efficacy of Ropivacaine on the reduction of opioids use
Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change
Measured: Day 21
Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change
Measured: Day 21
Systemic passage of Ropivacaine
Evaluation of the systemic passage of Ropivacaine
Measured: Blood test during the first bath with Ropivacaine up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start27 Feb 2017
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christine Bodemer, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisCéline Greco, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730584
- Sponsor's protocol ID
- D20180207
- Other IDs
- 2018-003334-33, 2018
- Acronym
- EBROPI
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2018
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno Artero E, Schinkel N, Chaumon S, Corset I, Rabeony T, Elie C, Bellon N, Bodemer C, Greco C. Efficacy of topical ropivacaine in children and young adults with hereditary epidermolysis bullosa. Br J Dermatol. 2021 Mar;184(3):550-552. doi: 10.1111/bjd.19551. Epub 2020 Nov 2. No abstract available.
PubMed 32939751Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarre C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Freard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socie G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15.
PubMed 28821470
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT03730584
- Acronym / sponsor ID
- EBROPI / D20180207
- Conditions
- Epidermolysis Bullosa
- Keywords
- Hereditary Epidermolysis Bullosa, pain, bath, dressing change, Ropivacaine, topical application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 5 Nov 2018 (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.
The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa.
Detailed description
This clinical trial aims to determine the efficacy on pain of local application of ROPIVACAINE 0.2% on cutaneous lesions related to Epidermolysis Bullosa during dressing change, associated with the standard premedication.
Patients will be hospitalized and will have several baths. The first bath will be done according to usual protocol (usual premedication 1h before the bath). Pain measurements (Visual analog scale or FLACC) will be done at the entry into the water, in the middle of bath and at the time of the dressing change.
The following baths will be done using local application of Ropivacaine 15 minutes before entering into the water on lesions identified by the patients as the most painful lesions due to Epidermolysis Bullosa.
A blood test will be done during the first use of Ropivacaine to determine plasmatic level of Ropivacaine.
After 3 baths in the dermatology unit, patients will continue such bath at home, every 48h during 15 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Hereditary Epidermolysis Bullosa | Experimental | Drug: Ropivacaine, Biological: Blood test |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa,
- Presenting pain at the entrance of the bath with an average of EVA or FLACC greater than 4/10 the week before the inclusion
- Usually requiring premedication with weak or strong opioid
- Parental consent if minor or patient consent
- Affiliated with Social Security
Key exclusion criteria (5 listed)
- Patient with a known allergy to ROPIVACAINE or other local anesthetics with amide binding or one of the excipients mentioned in the SPC
- Severe renal insufficiency defined by DFG below 29ml / min
- Moderate to severe hepatic insufficiency defined by a Child-Pugh B or C score and AST or ALAT greater than 3 times normal
- Moderate to severe cardiac failure defined by FEGV less than 45% and/or NYHA class II to IV
- Hypovolemia
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 |
|---|---|---|
| RopivacaineAmpoules of ROPIVACAINE 2mg / ml will be used by local cutaneous application in soft application with device of "hand shower" on the painful wounds without exceeding the dose of 1mg / kg per bath. | Drug | Patient with Hereditary Epidermolysis Bullosa |
| Blood testBlood test during the first bath with Ropivacaine for Titration of Ropivacaine | Biological | Patient with Hereditary Epidermolysis Bullosa |
Primary outcome
Efficacy on pain of Ropivacaine at the bath entrance
Time frame: Day 5
Evaluation performed by child with a Visual Analog Scale (VAS) or by parents with the Face Legs Activity Cry Consolability questionary (FLACC) - defined by a 2 points loss between day 1 and day 5
7 secondary outcomes
Efficacy on pain of Ropivacaine at the time of dressing change
Time frame: Day 5
Efficacy on pain of Ropivacaine at home at the time of dressing change
Time frame: Day 21
Efficacy on pain of Ropivacaine at home at bath entrance
Time frame: Day 21
Measurement of Local or systemic side effects
Time frame: Day 5
Efficacy of Ropivacaine on the reduction of opioids use
Time frame: Day 21
Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
Time frame: Day 21
Systemic passage of Ropivacaine
Time frame: Blood test during the first bath with Ropivacaine up to Day 4
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 20 Nov 2025.
- Results publication: PubMed 32939751Moreno Artero E, Schinkel N, Chaumon S, Corset I, Rabeony T, Elie C, Bellon N, Bodemer C, Greco C. Efficacy of topical ropivacaine in children and young adults with hereditary epidermolysis bullosa. Br J Dermatol. 2021 Mar;184(3):550-552. doi: 10.1111/bjd.19551. Epub 2020 Nov 2. No abstract available.
- Results publication: PubMed 28821470Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarre C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Freard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socie G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15.
- Individual participant dataSharing planned: No
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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.
Christine Bodemer, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Céline Greco, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Blood test in people with Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 5 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Efficacy on pain of Ropivacaine at the bath entrance (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730584, which also lists 2 linked publications.
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 20 Nov 2025.