Last updated on July 2018

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Brief description of study

This is 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.

Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness wounds in adults under the brand name Episalvan. 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 initiated to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long term use.

Oleogel-S10 will be compared to a vehicle gel placebo. The placebo is an identical looking sunflower oil gel that does not contain any active substance. The participant will receive either Oleogel-S10 or vehicle gel for a double-blind study phase of 90 days. The probability that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants will be treated with Oleogel S10 for a period of 24 months.

This clinical study will be performed in several countries in total, about 164 participants are expected to participate.

Clinical Study Identifier: NCT03068780

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Dédée F. Murrell, Prof.

Premier Specialists
Sydney, Australia
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Orli Wargon, A/Prof

Sydney Children's Hospital
Sydney, Australia
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Johannes Kern, MD

The Royal Melbourne Hospital
Parkville, Australia
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Susan Robertson, Dr

Murdoch Childrens Research Institute Royal Children's Hospital
Parkville, Australia
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Martin Laimer, Prof.

Universitaetsklinik fuer Dermatologie
Salzburg, Austria
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Christine Chiaverini, Dr.

CHU de l'Archet
Nice, France
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Christine Bodemer, Prof.

H pital Necker-Enfants Malades
Paris, France
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Franziska Schauer, Dr

Medical Center University Freiburg
Freiburg im Breisgau, Germany
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Hagen Ott, Dr.

Kinder- und Jugendkrankenhaus AUF DER BULT
Hannover, Germany
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Regina Foelster-Holst, Prof.

Hautklinik Kiel, UKSH, Campus Kiel
Kiel, Germany
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Alexandra Katsarou-Katsari, Dr.

Hospital of Skin and Veneral Diseases "A. Syggros"
Athens, Greece
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Ellis Hon Kam Lun, Prof.

Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
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Fiona Browne, Dr.

St James Hospital
Dublin, Ireland
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Fiona Browne, Dr.

Our Ladys Childrens Hospital
Dublin, Ireland
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Eli Sprecher, Prof.

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
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Paola Marchisio, Prof.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
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Andrea Diociaiuti, Dr.

Bambino Ges Children Hospital
Roma, Italy
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Biagio Didona, Dr.

Istituto Dermopatico dell'Immacolata IDI-IRCCS
Roma, Italy
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Elena Arana, Dr.

Hospital Universitari de la Vall d'Hebron
Barcelona, Spain
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Raul De Lucas, Dr

Hospital Universitario La Paz
Madrid, Spain
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Carolina Gouveia, Dr.

Bern University Hospital
Bern, Switzerland
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Malobi Ogboli, Dr.

Birmingham Children's Hospital NHS Trust
Birmingham, United Kingdom
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Anna Martinez, Dr.

Great Ormond Street hospital
London, United Kingdom
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Margarita Larralde, Dr.

Consutorios Medicos (Instituto de Neumonologia y Dermatologia)
Buenos Aires, Argentina
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Francis Palisson, Dr.

Fundacion Debra Chile
Santiago, Chile
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Hana Buckova, Dr.

University Hospital Brno, Children s Hospital
Brno, Czechia
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Juliette Mazereeuw-Hautier, Dr.

CHU Toulouse - Hospital Larrey
Toulouse, France
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Marie-Anne Morren, Dr.

Universitaire Ziekenhuizen Leuven
Leuven, Belgium
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Branka Marinovic, Prof. Dr.

University Hospital Center Zagreb
Zagreb, Croatia
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Mette Sommerlund, Dr.

Aarhus University Hospital
Aarhus, Denmark
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Miklos Sardy, Prof.

Semmelweis University, Faculty of Medicine
Budapest, Hungary
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Mark Jean Aan Koh, Dr.

Kandang Kerbau (KK) Women's and Children's Hospital
Singapore, Singapore
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Silvia Maria Barbosa, Dr.

Instituto Da Crianca HCFMUSP
São Paulo, Brazil
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Mauricio Torres, Dr.

Hospital De San Jose
Bogotá, Colombia
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