An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB.

SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.

Inclusion criteria

• ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.
• Subject (or caretaker) must be willing to comply with all protocol requirements.
• Subjects must complete the SD-007 study.

Exclusion criteria

• Subjects who do not meet the entry criteria outlined above.
• Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator)
• Participant is one of the following:

• Not of childbearing potential (premenarchal or male/not in possession of a uterus).
• If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:

• Abstinence from heterosexual intercourse as a lifestyle choice.
• Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.
• Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.