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

PHASE3CompletedINTERVENTIONAL
Enrollment

223

Participants

Timeline

Start Date

March 29, 2017

Primary Completion Date

June 11, 2020

Study Completion Date

May 27, 2022

Conditions
Epidermolysis Bullosa
Interventions
DRUG

Oleogel-S10

10% birch bark extract in 90% sunflower oil

DRUG

Control gel

Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)

Trial Locations (51)

159

S/R National Center of Dermatology and Venerology, Tbilisi

1085

Semmelweis University, Faculty of Medicine, Budapest

1425

Consutorios Medicos (Instituto de Neumonologia y Dermatologia), Buenos Aires

1426

Centro Médico Dra. De Salvo, Buenos Aires

2031

Sydney Children's Hospital, Sydney

2217

Premier Specialists, Sydney

3010

Bern University Hospital, Bern

3050

The Royal Melbourne Hospital, Parkville

3502

Murdoch Childrens Research Institute Royal Children's Hospital, Parkville

5020

Universitaetsklinik fuer Dermatologie, Salzburg

8000

Aarhus University Hospital, Aarhus

8035

Hospital Universitari de la Vall d'Hebron, Barcelona

11000

University of Belgrade, School of Medicine, Belgrade

11790

Stony Brook University Hospital, Stony Brook

16121

"Hospital of Skin and Veneral Diseases A. Syggros", Athens

19104

The Children's Hospital of Philadelphia, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

28046

Hospital Universitario La Paz, Madrid

29425

Medical University of South Carolina, Charleston

30173

Kinder- und Jugendkrankenhaus AUF DER BULT, Hanover

31059

CHU Toulouse - Hospital Larrey, Toulouse

33144

Amjad Plastic Research, Miami

41014

Hospital Viamed Santa Ángela de la Cruz, Seville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

55455

University of Minnesota, Minneapolis

61500

University Hospital Brno, Children´s Hospital, Brno

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

75015

Hôpital Necker-Enfants Malades, Paris

78218

Texas Dermatology and Laser Specialists, San Antonio

79104

Medical Center University Freiburg, Freiburg im Breisgau

80045

Children's Hospital Colorado, Aurora

85016

Phoenix Children's Hospital, Phoenix

107076

State Scientific Center for Dermatovenerology and Cosmetology, Moscow

119991

Scientific Center of Children's Health, Moscow

229899

Kandang Kerbau (KK) Women's and Children's Hospital, Singapore

7760099

Fundacion Debra Chile, Santiago

50070550

IMIP, Recife

89020400

Universidade Regional de Blumenau, Blumenau

C1056ABJ

Centro de investigaciones Metabolicas, CINME, Buenos Aires

05403.000

Instituto Da Crianca HCFMUSP, São Paulo

Unknown

Hospital De San Jose, Bogotá

Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong

Our Ladys Childrens Hospital, Dublin

Birmingham Children's Hospital NHS Trust, Birmingham

00165

Bambino Gesù Children Hospital, Roma

00167

Istituto Dermopatico dell'Immacolata IDI-IRCCS, Roma

011025

Centrul Medical Sanador, Bucharest

08950

Hospital Sant Joan de Déu, Barcelona

01135

"National Children Specialized Hospital Ohmatdyt of Ministry of Health of Ukraine", Kyiv

WC1N3JH

Great Ormond Street hospital, London

Sponsors
All Listed Sponsors
lead

Amryt Research Limited

INDUSTRY