Epidermolysis BullosaPhase 3EASENCT03068780
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
A Phase 3 study testing Oleogel-S10 in people with Epidermolysis Bullosa, run by Amryt Research Limited at 51 sites in 26 countries.
Trial summary
This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB). EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. Read more about this study
- Who is it for?
- Ages 21 days and older
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- Oleogel-S10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 51 sitesin 26 countries
- Study dates
- 29 Mar 2017to 27 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler EB aged ≥21 days
- Patients with an EB target wound (i.e., EB partial thickness wound of 10 cm² to 50 cm² in size aged ≥21 days and <9 months)
- Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed consent form, and has/have given written informed consent
- Patient and/or his/her legal representative must be able and willing to follow study procedures and instructions
Who cannot join
- Patient has EB simplex
- EB target wound that is ≥9 months old or has clinical signs of local infection
- Use of systemic antibiotics for wound-related infections within 7 days prior to enrolment
- Administration of systemic or topical steroids (except for inhaled, ophthalmic or topical applications, such as budesonide suspension for oesophageal strictures [e.g., Pulmicort respules® 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrolment
- Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment
- Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB
Show all 12Show fewer
- Current and/or former malignancy including basal cell carcinomas and squamous cell carcinomas
- Enrolment in any interventional study or treated with any investigational drug for any disease within 4 weeks prior to study entry
- Factors present in the patient and/or his/her legal representative that could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes
- Pregnant or nursing women and women of childbearing potential including postmenarchal female adolescents not willing to use an effective form of birth control with failure rates <1% per year (e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomised partner) during participation in the study (and at least 3 months thereafter)
- Patient is a member of the investigational team or his/her immediate family
- Patient lives in the same household as a study participant
Trial locations and contacts
51 sites in 26 countries.
51 sites in 26 countries
United States10 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Amjad Plastic Research
Miami, Florida, 33144
University of Minnesota
Minneapolis, Minnesota, 55455
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Stony Brook University Hospital
Stony Brook, New York, 11790
Australia4 sites
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Murdoch Childrens Research Institute Royal Children's Hospital
Parkville, Victoria, 3502
Sydney Children's Hospital
Sydney, New South Wales, 2031
Premier Specialists
Sydney, New South Wales, 2217
Spain4 sites
Hospital Sant Joan de Déu
Barcelona, 08950
Hospital Universitari de la Vall d'Hebron
Barcelona, 8035
Hospital Universitario La Paz
Madrid, 28046
Hospital Viamed Santa Ángela de la Cruz
Seville, 41014
Argentina3 sites
Consutorios Medicos (Instituto de Neumonologia y Dermatologia)
Buenos Aires, 1425
Centro Médico Dra. De Salvo
Buenos Aires, 1426
Centro de investigaciones Metabolicas, CINME
Buenos Aires, C1056ABJ
Brazil3 sites
Universidade Regional de Blumenau
Blumenau, Santa Catarina, 89020400
IMIP
Recife, Pernanbuco, 50070550
Instituto Da Crianca HCFMUSP
São Paulo, 05403.000
Italy3 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Bambino Gesù Children Hospital
Roma, 00165
Istituto Dermopatico dell'Immacolata IDI-IRCCS
Roma, 00167
France2 sites
Hôpital Necker-Enfants Malades
Paris, 75015
CHU Toulouse - Hospital Larrey
Toulouse, 31059
Germany2 sites
Medical Center University Freiburg
Freiburg im Breisgau, 79104
Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, 30173
Russia2 sites
State Scientific Center for Dermatovenerology and Cosmetology
Moscow, 107076
Scientific Center of Children's Health
Moscow, 119991
United Kingdom2 sites
Birmingham Children's Hospital NHS Trust
Birmingham
Great Ormond Street hospital
London, WC1N3JH
Greece1 site
Hospital of Skin and Veneral Diseases "A. Syggros"
Athens, Attica, 16121
Hong Kong1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Singapore1 site
Kandang Kerbau (KK) Women's and Children's Hospital
Singapore, 229899
Ukraine1 site
National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine
Kyiv, 01135
About this study
Official title: Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa
This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB).
EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing.
Read more
The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.
This clinical study of Oleogel-S10 in patients with inherited EB has been carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use.
Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months.
This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong [China], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States); 223 participants participated in total.
- Conditions
- Epidermolysis Bullosa
- Being tested
- Oleogel-S10, Control gel
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10Drug
Also called Episalvan, Filsuvez
10% birch bark extract in 90% sunflower oil
Control gelDrug
Also called Vehicle gel
Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)
| Study group | Role | What they receive |
|---|---|---|
| Oleogel-S10 | Experimental | Not described Receives: Drug: Oleogel-S10 |
| Control Gel | Placebo comparator | Not described Receives: Drug: Control gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
Proportion of subjects with first complete closure of the EB target wound (defined as EB partial-thickness wound of 10 cm2 to 50 cm2 in size and ≥21 days to <9 months in age) in subjects with inherited EB (subtypes DEB, JEB, or Kindler EB) within 45 days of treatment with Oleogel-S10 compared to control gel based on clinical assessment by the investigator (the wound was rated as "closed" at first appearance of complete re-epithelialization without drainage).
Measured: 45±7 days
Secondary outcomes (7)
Time to First Complete Closure of the EB Target Wound as Evidenced by Clinical Assessment Until Day 90 (D90) or End of Double-blind Phase (EDBP)
The first key secondary endpoint was time to first complete closure of the EB target wound as evidenced by clinical assessment within 90 days or by EDBP, using a nonstratified log-rank test.
If the primary analysis of the primary efficacy endpoint showed superiority at the 5% significance level, hierarchical confirmatory testing of the 6 key secondary endpoints was to be performed.
Measured: 90±7 days
Proportion of Patients With First Complete Closure of the EB Target Wound at D90 or EDBP Based on Clinical Assessment by the Investigator Until D90 or EDBP
The second key secondary endpoint was the proportion of subjects with first complete closure of the EB target wound within 90 days of treatment or by EDBP based on clinical assessment by the investigator.
Measured: 90±7 days
The Incidence of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by Adverse Events (AEs) and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)
The incidence of EB target wound infections between Baseline (DBP D0) and D90 or EDBP was assessed based on the total number of patients with an EB target wound infection, as evidenced by AEs and/or the use of topical and/or systemic antibiotics, and the total number of patients
Measured: 90±7 days
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Target wound infections between baseline (DBP D0) and D90 or EDBP were assessed for maximum severity (maximum severity was evaluated if a subject had a wound infection event evidenced by AEs). [Note: Here, 1 event less is recorded in the control gel group as for the previous secondary outcome measure, because only wound infections that were reported as AEs could be assessed for severity and were included in this analysis.]
Measured: 90±7 days
Change From Baseline (DBP D0) in Total Body Wound Burden as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI), at D90 or EDBP
The evaluation of total body wound burden (TBWB) was based on clinical assessment using Section I (Skin) of the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). The EBDASI skin activity (blistering/erosions/crusting) was scored from 0 to 10 for each of 10 anatomical locations (excluding the anogenital and buttocks regions). Therefore, the total skin activity score (i.e., TBWB) could range from 0 to 100, with lower scores indicative of less wound burden. The change in TBWB was assessed from baseline (DBP D0) to D90 or EDBP.
Measured: 90±7 days
Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90 or EDBP
Change from Baseline at D90 or EDBP on the Itch Man Scale in patients 4-13 years of age. The scale runs from 0 (comfortable, no itch) to 4 (itches most terribly, impossible to sit still, concentrate).
Measured: 90±7 days
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Change in Leuven Itch Scale (patients ≥ 14 years of age) scores taken from two time points, Baseline and Day 90±7 [End of Double Blind Phase (EDBP)]. The Leuven Itch Scale measures six dimensions of the itch experience: Frequency Subscore (0 = Never to 100 = Always); Duration Subscore (0 = Between 0 and 30 minutes to 100 = More than 2 hours); Severity Subscore (0 = No itch to 100 = Worst possible itch); Consequences Subscore [0 = Never to 100 = Always (lower score indicates less negative consequences from the itch)]; Distress Subscore (0 = Not distressing at all to 100 = Very distressing); Surface Area Subscore (0-100, high values indicate more parts of the body are itching)
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start29 Mar 2017
- Primary completion11 Jun 2020
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amryt Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes S Kern, MD PhD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068780
- Sponsor's protocol ID
- BEB-13
- Other IDs
- 2016-002066-32, 2016
- Acronym
- EASE
- Status last verified
- Jul 2023
- First submitted
- 27 Feb 2017
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Sprecher E, Torres-Pradilla M, Fernandez MF, Bodemer C, Bruckner AL, de Macedo Barbosa SM, Diociaiuti A, Martinez AE, Palisson F, Nikolic M, Vicente A, de Lucas R, Temin NT, Lowe S, Kern JS, Murrell DF; EASE Study Group. Long-Term Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa. Pediatr Dermatol. 2026 May 28. doi: 10.1111/pde.70224. Online ahead of print.
PubMed 42205007Kern JS, Schwieger-Briel A, Lowe S, Sumeray M, Davis C, Martinez AE. Oleogel-S10 Phase 3 study "EASE" for epidermolysis bullosa: study design and rationale. Trials. 2019 Jun 11;20(1):350. doi: 10.1186/s13063-019-3362-z.
PubMed 31186047
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT03068780
- Acronym / sponsor ID
- EASE / BEB-13
- Conditions
- Epidermolysis Bullosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Amryt Research LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB).
EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing.
The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.
This clinical study of Oleogel-S10 in patients with inherited EB has been carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use.
Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months.
This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong [China], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States); 223 participants participated in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oleogel-S10 | Experimental | Drug: Oleogel-S10 |
| Control Gel | Placebo comparator | Drug: Control gel |
Who may qualify
- Ages
- 21 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler EB aged ≥21 days
- Patients with an EB target wound (i.e., EB partial thickness wound of 10 cm² to 50 cm² in size aged ≥21 days and <9 months)
- Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed consent form, and has/have given written informed consent
- Patient and/or his/her legal representative must be able and willing to follow study procedures and instructions
Key exclusion criteria (12 listed)
- Patient has EB simplex
- EB target wound that is ≥9 months old or has clinical signs of local infection
- Use of systemic antibiotics for wound-related infections within 7 days prior to enrolment
- Administration of systemic or topical steroids (except for inhaled, ophthalmic or topical applications, such as budesonide suspension for oesophageal strictures [e.g., Pulmicort respules® 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrolment
- Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment
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 |
|---|---|---|
| Oleogel-S10Also: Episalvan, Filsuvez10% birch bark extract in 90% sunflower oil | Drug | Oleogel-S10 |
| Control gelAlso: Vehicle gelSunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance) | Drug | Control Gel |
Primary outcome
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
Time frame: 45±7 days
Proportion of subjects with first complete closure of the EB target wound (defined as EB partial-thickness wound of 10 cm2 to 50 cm2 in size and ≥21 days to <9 months in age) in subjects with inherited EB (subtypes DEB, JEB, or Kindler EB) within 45 days of treatment with Oleogel-S10 compared to control gel based on clinical assessment by the investigator (the wound was rated as "closed" at first appearance of complete re-epithelialization without drainage).
7 secondary outcomes
Time to First Complete Closure of the EB Target Wound as Evidenced by Clinical Assessment Until Day 90 (D90) or End of Double-blind Phase (EDBP)
Time frame: 90±7 days
Proportion of Patients With First Complete Closure of the EB Target Wound at D90 or EDBP Based on Clinical Assessment by the Investigator Until D90 or EDBP
Time frame: 90±7 days
The Incidence of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by Adverse Events (AEs) and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)
Time frame: 90±7 days
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Time frame: 90±7 days
Change From Baseline (DBP D0) in Total Body Wound Burden as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI), at D90 or EDBP
Time frame: 90±7 days
Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90 or EDBP
Time frame: 90±7 days
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Time frame: 90±7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42205007Sprecher E, Torres-Pradilla M, Fernandez MF, Bodemer C, Bruckner AL, de Macedo Barbosa SM, Diociaiuti A, Martinez AE, Palisson F, Nikolic M, Vicente A, de Lucas R, Temin NT, Lowe S, Kern JS, Murrell DF; EASE Study Group. Long-Term Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa. Pediatr Dermatol. 2026 May 28. doi: 10.1111/pde.70224. Online ahead of print.
- Derived from this study: PubMed 31186047Kern JS, Schwieger-Briel A, Lowe S, Sumeray M, Davis C, Martinez AE. Oleogel-S10 Phase 3 study "EASE" for epidermolysis bullosa: study design and rationale. Trials. 2019 Jun 11;20(1):350. doi: 10.1186/s13063-019-3362-z.
- 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.
Johannes S Kern, MD PhD principal investigator
Melbourne Health
51 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oleogel-S10 in people with Epidermolysis Bullosa, run by Amryt Research Limited at 51 sites in 26 countries.
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 4 inclusion and 12 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Australia, Spain, Argentina, Brazil and 21 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment (time frame: 45±7 days). 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 NCT03068780, 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 Jul 2023.