. 2019 Jun 11;20:350. doi: 10.1186/s13063-019-3362-z

Table 2.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Male and female patients with JEB, DEB, or Kindler syndrome aged ≥ 4 years (children aged < 4 years may be included only after confirmation by the Independent Data Monitoring Committee upon review of the safety and bioanalytical data at the interim safety review stage) Patients with an EB target wound (i.e. EB partial thickness wound of 10–50 cm² in size aged ≥ 21 days and < 9 months) with no signs of local infection 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	Patients with EBS EB target wound with clinical signs of local infection Use of systemic antibiotics for wound-related infections within 7 days before enrollment Administration of systemic or topical steroids (except for inhaled, ophthalmic, or topical applications, such as budesonide suspension for esophageal strictures [e.g. Pulmicort Respules® 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrollment Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before enrollment 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 Enrollment in any interventional study or treated with any investigational drug for any disease within 4 weeks before 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 Women of childbearing potential including post-menarchal female adolescents and men who are 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, vasectomy, or vasectomized 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

Inclusion criteria

Exclusion criteria

Male and female patients with JEB, DEB, or Kindler syndrome aged ≥ 4 years (children aged < 4 years may be included only after confirmation by the Independent Data Monitoring Committee upon review of the safety and bioanalytical data at the interim safety review stage)

Patients with an EB target wound (i.e. EB partial thickness wound of 10–50 cm² in size aged ≥ 21 days and < 9 months) with no signs of local infection

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

Patients with EBS

EB target wound with clinical signs of local infection

Use of systemic antibiotics for wound-related infections within 7 days before enrollment

Administration of systemic or topical steroids (except for inhaled, ophthalmic, or topical applications, such as budesonide suspension for esophageal strictures [e.g. Pulmicort Respules® 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrollment

Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before enrollment

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

Enrollment in any interventional study or treated with any investigational drug for any disease within 4 weeks before 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

Women of childbearing potential including post-menarchal female adolescents and men who are 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, vasectomy, or vasectomized 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

EB epidermolysis bullosa, DEB dystrophic EB, EBS EB simplex, JEB junctional EB