Back to resultsPhase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE)
Primary Purpose
Epidermolysis Bullosa
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oleogel-S10
Control gel
Sponsored by
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler syndrome 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.
Exclusion Criteria:
- Patient has EB simplex
- EB target wound with 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,
- 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.
Sites / Locations
- Phoenix Children's Hospital
- Children's Hospital Colorado
- Amjad Plastic Research
- University of Minnesota
- Stony Brook University Hospital
- Cincinnati Children's Hospital Medical Center
- The Children's Hospital of Philadelphia
- Thomas Jefferson University Hospital
- Medical University of South Carolina
- Texas Dermatology and Laser Specialists
- Consutorios Medicos (Instituto de Neumonologia y Dermatologia)
- Centro Médico Dra. De Salvo
- Centro de investigaciones Metabolicas, CINME
- Sydney Children's Hospital
- Premier Specialists
- The Royal Melbourne Hospital
- Murdoch Childrens Research Institute Royal Children's Hospital
- Universitaetsklinik fuer Dermatologie
- IMIP
- Universidade Regional de Blumenau
- Instituto Da Crianca HCFMUSP
- Fundacion Debra Chile
- Hospital De San Jose
- University Hospital Brno, Children´s Hospital
- Aarhus University Hospital
- Hôpital Necker-Enfants Malades
- CHU Toulouse - Hospital Larrey
- S/R National Center of Dermatology and Venerology
- Medical Center University Freiburg
- Kinder- und Jugendkrankenhaus AUF DER BULT
- Hospital of Skin and Veneral Diseases "A. Syggros"
- Prince of Wales Hospital, The Chinese University of Hong Kong
- Semmelweis University, Faculty of Medicine
- Our Ladys Childrens Hospital
- Tel Aviv Sourasky Medical Center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Bambino Gesù Children Hospital
- Istituto Dermopatico dell'Immacolata IDI-IRCCS
- Centrul Medical Sanador
- State Scientific Center for Dermatovenerology and Cosmetology
- Scientific Center of Children's Health
- University of Belgrade, School of Medicine
- Kandang Kerbau (KK) Women's and Children's Hospital
- Hospital Sant Joan de Déu
- Hospital Universitari de la Vall d'Hebron
- Hospital Universitario La Paz
- Hospital Viamed Santa Ángela de la Cruz
- Bern University Hospital
- National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine
- Birmingham Children's Hospital NHS Trust
- Great Ormond Street hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oleogel-S10
Control Gel
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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
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.]
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.
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).
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03068780
Brief Title
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
Acronym
EASE
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
May 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amryt Research Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oleogel-S10
Arm Type
Experimental
Arm Title
Control Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oleogel-S10
Other Intervention Name(s)
Episalvan, Filsuvez
Intervention Description
10% birch bark extract in 90% sunflower oil
Intervention Type
Drug
Intervention Name(s)
Control gel
Other Intervention Name(s)
Vehicle gel
Intervention Description
Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)
Primary Outcome Measure Information:
Title
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
Description
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).
Time Frame
45±7 days
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
90±7 days
Title
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
Description
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.
Time Frame
90±7 days
Title
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)
Description
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
Time Frame
90±7 days
Title
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Description
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.]
Time Frame
90±7 days
Title
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
Description
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.
Time Frame
90±7 days
Title
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
Description
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).
Time Frame
90±7 days
Title
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)
Description
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)
Time Frame
90±7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes S Kern, MD PhD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Amjad Plastic Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Consutorios Medicos (Instituto de Neumonologia y Dermatologia)
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Centro de investigaciones Metabolicas, CINME
City
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Sydney Children's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Premier Specialists
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Murdoch Childrens Research Institute Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3502
Country
Australia
Facility Name
Universitaetsklinik fuer Dermatologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
IMIP
City
Recife
State/Province
Pernanbuco
ZIP/Postal Code
50070550
Country
Brazil
Facility Name
Universidade Regional de Blumenau
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89020400
Country
Brazil
Facility Name
Instituto Da Crianca HCFMUSP
City
São Paulo
ZIP/Postal Code
05403.000
Country
Brazil
Facility Name
Fundacion Debra Chile
City
Santiago
ZIP/Postal Code
7760099
Country
Chile
Facility Name
Hospital De San Jose
City
Bogotá
State/Province
DC
Country
Colombia
Facility Name
University Hospital Brno, Children´s Hospital
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU Toulouse - Hospital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
S/R National Center of Dermatology and Venerology
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Medical Center University Freiburg
City
Freiburg im Breisgau
ZIP/Postal Code
79104
Country
Germany
Facility Name
Kinder- und Jugendkrankenhaus AUF DER BULT
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Hospital of Skin and Veneral Diseases "A. Syggros"
City
Athens
State/Province
Attiki
ZIP/Postal Code
16121
Country
Greece
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis University, Faculty of Medicine
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Our Ladys Childrens Hospital
City
Dublin
Country
Ireland
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Bambino Gesù Children Hospital
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Istituto Dermopatico dell'Immacolata IDI-IRCCS
City
Roma
ZIP/Postal Code
00167
Country
Italy
Facility Name
Centrul Medical Sanador
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
State Scientific Center for Dermatovenerology and Cosmetology
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Scientific Center of Children's Health
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
University of Belgrade, School of Medicine
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Kandang Kerbau (KK) Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitari de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Viamed Santa Ángela de la Cruz
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Birmingham Children's Hospital NHS Trust
City
Birmingham
Country
United Kingdom
Facility Name
Great Ormond Street hospital
City
London
ZIP/Postal Code
WC1N3JH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
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