Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amryt Research Limited
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler EB aged ≥21 days
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
You may not be if
Patient has EB simplex
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
