Epidermolysis Bullosa
Conditions
Interventions
Arm 1: Birch bark extract (Oleogel-S10) and a non-adhesive wound dressings, for 90 days, 82 patients
Arm 2: Vehicle (placebo) and an non-adhesive wound dressings, for 90 days, 82 patients
After this
Drug
Sponsors
Hospital da Criança Santo Antônio - Irmandade Santa Casa de Misericórdia de Porto Alegre
Inc Research Br Serviços de Pesquisa Clínica LTDA
Amryt Research Limited
Eligibility
Age
4 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients with any subtype of inherited Epidermolyse bullosa age more than 4 years; Patients with an Epidermolyse bullosa target wound; 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
Exclusion criteria: Epidermolyse bullosa target wound with clinical signs of local infection; Use of systemic antibiotics for wound-related infections within seven days prior to enrolment; Administration of systemic or topical steroids 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; 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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation by clinical exam of the complete closure of the EB target wound within 45±7 days of treatment, comparing the usage of Oleogel-S10 and Placebo. Statistical analysis of the primary endpoint will be performed by Cui, Hung, Wang (CHW) method. | — |
Countries
Argentina, Australia, Austria, Brazil, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Singapore, Spain, Switzerland, United Kingdom
Contacts
Public ContactLivia Gomes
Inc Research Br Serviços de Pesquisa Clínica LTDA
Outcome results
None listed