Epidermolysis Bullosa DystrophicaPhase 2NCT00951964
Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
A Phase 2 study of Epidermolysis Bullosa Dystrophica, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
Trial summary
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma. These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2010to Jul 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- known mutation of COL7A1
Who cannot join
- tea drinkers
- patient receiving induction treatment,protease inhibitor treatment
- liver failure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Dermatology Department, Bordeaux University Hospital
Bordeaux
Dijon University Hospital, Dermatology Department
Dijon
Dermatology Department, Necker Enfants Malades, APHP
Paris
Dermatology Department, Saint Louis Hospital, APHP
Paris
Toulouse University Hospital, Dermatology Department
Toulouse
About this study
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.
These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.
Read more
The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.
The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.
The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.
Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.
This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.
When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.
- Conditions
- Epidermolysis Bullosa Dystrophica
- Being tested
- Polyphenon E before Placebo, placebo before treatment
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon E before PlaceboDrug
patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
placebo before treatmentDrug
patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | patients receive the treatment in first and placebo in second part of study Receives: Drug: Polyphenon E before Placebo |
| 2 | Other | patients receive placebo in first and treatment in second part of study Receives: Drug: placebo before treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease of number of cutaneous bullosa
Measured: after 4 months of treatment
Secondary outcomes (2)
efficacity of treatment
Measured: at 4 , 6, 7 10 months after beginnig of treatment and at year 1
tolerance tio treatment
Measured: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis Bullosa DystrophicaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chiaverini, PhD, Principal investigator, dermatology department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951964
- Sponsor's protocol ID
- 09-APN-01
- Status last verified
- May 2014
- First submitted
- 3 Aug 2009
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiaverini C, Roger C, Fontas E, Bourrat E, Bourdon-Lanoy E, Labreze C, Mazereeuw J, Vabres P, Bodemer C, Lacour JP. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial. Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.
PubMed 27015660
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
- ClinicalTrials.gov ID
- NCT00951964
- Acronym / sponsor ID
- 09-APN-01
- Conditions
- Epidermolysis Bullosa Dystrophica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Aug 2009 (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.
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.
These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.
The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.
The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.
The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.
Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.
This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.
When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Polyphenon E before Placebopatients receive the treatment in first and placebo in second part of study |
| 2 | Other | Drug: placebo before treatmentpatients receive placebo in first and treatment in second part of study |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- known mutation of COL7A1
Key exclusion criteria (3 listed)
- tea drinkers
- patient receiving induction treatment,protease inhibitor treatment
- liver failure
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 |
|---|---|---|
| Polyphenon E before Placebopatients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo | Drug | 1 |
| placebo before treatmentpatients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment | Drug | 2 |
Primary outcome
decrease of number of cutaneous bullosa
Time frame: after 4 months of treatment
2 secondary outcomes
efficacity of treatment
Time frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1
tolerance tio treatment
Time frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment
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 7 May 2014.
- Derived from this study: PubMed 27015660Chiaverini C, Roger C, Fontas E, Bourrat E, Bourdon-Lanoy E, Labreze C, Mazereeuw J, Vabres P, Bodemer C, Lacour JP. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial. Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.
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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 Chiaverini, PhD principal investigator
dermatology department, Nice University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Epidermolysis Bullosa Dystrophica, run by Centre Hospitalier Universitaire de Nice at 5 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 1 inclusion and 3 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
decrease of number of cutaneous bullosa (time frame: after 4 months of treatment). 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 NCT00951964, which also lists 1 linked publication.
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 7 May 2014.