This study is an international clinical trial for people with Epidermolysis Bullosa Simplex (EBS).
Participants will be randomly assigned to use either diacerein 1% ointment (AC-203) or a control ointment once daily for 8 weeks, without knowing which ointment they are using. After an additional 8-week period without treatment, all participants will use diacerein 1% ointment (AC-203) for 24 weeks. Participants will report outcomes, including pain, itching, and quality of life at each visit.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.