Epidermolysis Bullosa Dystrophica, RecessivePhase 3MABULNCT02286427
A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane
A Phase 3 study testing Amniotic Membrane in people with Epidermolysis Bullosa Dystrophica, Recessive and Ulcer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica, Recessive, Ulcer
- What is being tested?
- Amniotic Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2020
- Phase
- Phase 3
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 2 years and 60
- REBD clinically evident with immunohistological confirmation and / or genetic
- REBD with at least two chronic ulcers (> 3 months) comparable
- Signing the informed consent of the patient and / or (children) of parents holding parental authority
- Affiliation to a social security scheme (beneficiary or legal)
Who cannot join
- Epidermoid carcinoma on the target or chronic ulcers
- Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
- Skin bacterial superinfection clinically overt requiring oral antibiotics
- Herpes simplex virus superinfection
- major evolutionary and malnutrition defined as a BMI <12 or more than 2 variant between screening and randomization OR a serum albumin <20 g / l or more ranging from 5 g / l between screening and randomization
- major and progressive anemia defined by a Hb <6 g / liter or variant more than 4 g / l between screening and randomization
Show all 10Show fewer
- Life expectancy estimated at less than 3 months
- Pregnancy
- Inability to understand or observance of the rules of protocol
- Participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in Mabul
Trial locations and contacts
1 site in 1 country.
emmanuelle BOURRAT, MD contact
France1 site, 1 recruiting
- Recruiting
Saint-Louis Hospital
Paris, Paris, 75010
emmannuelle bourrat, md, 142499742 ext. 33, emmanuelle.bourrat@aphp.fr
matthieu resche-rigon, md phd, 142499742 ext. 33, matthieu.resche-rigon@univ-paris-diderot.fr
About this study
Official title: A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.
Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.
The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.
- Being tested
- Amniotic Membrane
- Medical subject headings
- Epidermolysis Bullosa Dystrophica, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic MembraneDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard Dressing | Active comparator | J0 to J42 : once a week, primary dressing with Mepitel® Receives: Device: Amniotic Membrane |
| Amniotic Membrane | Experimental | J0 to J42: once a week, Mepitel® and amniotic membrane (one or several depending on the graft size, so that the ulcer was completely covered with MAH). The last amniotic membrane is left in place. Receives: Device: Amniotic Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ulcerated area re-epithelialised
Measured: at 12 weeks from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa Dystrophica, RecessiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286427
- Sponsor's protocol ID
- P130907 - 2014-001805-42
- Acronym
- MABUL
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.
- ClinicalTrials.gov ID
- NCT02286427
- Acronym / sponsor ID
- MABUL / P130907 - 2014-001805-42
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 Nov 2014 (estimated)
- 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.
Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.
The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dressing | Active comparator | Device: Amniotic MembraneJ0 to J42 : once a week, primary dressing with Mepitel® |
| Amniotic Membrane | Experimental | Device: Amniotic MembraneJ0 to J42: once a week, Mepitel® and amniotic membrane (one or several depending on the graft size, so that the ulcer was completely covered with MAH). The last amniotic membrane is left in place. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 2 years and 60
- REBD clinically evident with immunohistological confirmation and / or genetic
- REBD with at least two chronic ulcers (> 3 months) comparable
- Signing the informed consent of the patient and / or (children) of parents holding parental authority
- Affiliation to a social security scheme (beneficiary or legal)
Key exclusion criteria (10 listed)
- Epidermoid carcinoma on the target or chronic ulcers
- Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
- Skin bacterial superinfection clinically overt requiring oral antibiotics
- Herpes simplex virus superinfection
- major evolutionary and malnutrition defined as a BMI <12 or more than 2 variant between screening and randomization OR a serum albumin <20 g / l or more ranging from 5 g / l between screening and randomization
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 |
|---|---|---|
| Amniotic Membrane | Device | Amniotic Membrane, Standard Dressing |
Primary outcome
Percentage of ulcerated area re-epithelialised
Time frame: at 12 weeks from the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Related trials for Epidermolysis Bullosa Dystrophica, Recessive
Not yet recruitingPhase 4
Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds
Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Enrolling by invitationObservational study
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
RDEB
RecruitingObservational study
A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting
Recessive Dystrophic Epidermolysis Bullosa
Not yet recruiting
Treatment of Dysphagia in Patients With Dystrophic Epidermolysis Bullosa With Budesonide: a Retrospective Bicentric Study Nice - Paris St Louis / Necker (EBUDE Study)
Recessive Dystrophic Epidermolysis Bullosa, Dysphagia
RecruitingPhase 1/2
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita
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.
emmanuelle BOURRAT, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amniotic Membrane in people with Epidermolysis Bullosa Dystrophica, Recessive and Ulcer, 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 10 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: status not confirmed, as of the sponsor's last update on 4 Nov 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact matthieu resche-rigon, MD-PHD (142499742 ext. +33, matthieu.resche-rigon@univ-paris-diderot.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of ulcerated area re-epithelialised (time frame: at 12 weeks from the start of treatment). 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 4 Nov 2016.