Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
NCT ID: NCT03068780
Last Updated: 2023-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
223 participants
INTERVENTIONAL
2017-03-29
2022-05-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Oleogel-S10
Oleogel-S10
10% birch bark extract in 90% sunflower oil
Control Gel
Control gel
Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)
Interventions
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Oleogel-S10
10% birch bark extract in 90% sunflower oil
Control gel
Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Days
ALL
No
Sponsors
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Amryt Research Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Johannes S Kern, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Amjad Plastic Research
Miami, Florida, United States
University of Minnesota
Minneapolis, Minnesota, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Consutorios Medicos (Instituto de Neumonologia y Dermatologia)
Buenos Aires, , Argentina
Centro Médico Dra. De Salvo
Buenos Aires, , Argentina
Centro de investigaciones Metabolicas, CINME
Buenos Aires, , Argentina
Sydney Children's Hospital
Sydney, New South Wales, Australia
Premier Specialists
Sydney, New South Wales, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Murdoch Childrens Research Institute Royal Children's Hospital
Parkville, Victoria, Australia
Universitaetsklinik fuer Dermatologie
Salzburg, , Austria
IMIP
Recife, Pernanbuco, Brazil
Universidade Regional de Blumenau
Blumenau, Santa Catarina, Brazil
Instituto Da Crianca HCFMUSP
São Paulo, , Brazil
Fundacion Debra Chile
Santiago, , Chile
Hospital De San Jose
Bogotá, DC, Colombia
University Hospital Brno, Children´s Hospital
Brno, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Hôpital Necker-Enfants Malades
Paris, , France
CHU Toulouse - Hospital Larrey
Toulouse, , France
S/R National Center of Dermatology and Venerology
Tbilisi, , Georgia
Medical Center University Freiburg
Freiburg im Breisgau, , Germany
Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, , Germany
Hospital of Skin and Veneral Diseases "A. Syggros"
Athens, Attica, Greece
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Semmelweis University, Faculty of Medicine
Budapest, , Hungary
Our Ladys Childrens Hospital
Dublin, , Ireland
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Bambino Gesù Children Hospital
Roma, , Italy
Istituto Dermopatico dell'Immacolata IDI-IRCCS
Roma, , Italy
Centrul Medical Sanador
Bucharest, , Romania
State Scientific Center for Dermatovenerology and Cosmetology
Moscow, , Russia
Scientific Center of Children's Health
Moscow, , Russia
University of Belgrade, School of Medicine
Belgrade, , Serbia
Kandang Kerbau (KK) Women's and Children's Hospital
Singapore, , Singapore
Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital Universitari de la Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Viamed Santa Ángela de la Cruz
Seville, , Spain
Bern University Hospital
Bern, , Switzerland
National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine
Kyiv, , Ukraine
Birmingham Children's Hospital NHS Trust
Birmingham, , United Kingdom
Great Ormond Street hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002066-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BEB-13
Identifier Type: -
Identifier Source: org_study_id
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