Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

Launched by SCIODERM, INC. · Mar 16, 2014

Keywords

ClinConnect Summary

This was an open-label extension study to assess the continued safety of topically applied SD-101 dermal cream (6%) in participants with Simplex, Recessive Dystrophic, and Junctional non-Herlitz EB.

SD-101 dermal cream (6%) was applied topically, once a day to the entire body for the duration of the study. Participants who successfully completed the entire SD-003 study (NCT02014376) had the option to roll over into the SD-004 study (NCT02090283). The baseline visit occurred at the final visit date for the SD-003 study. The body surface area (BSA) coverage of blisters and lesions assessment...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent form signed by the participant or participant's legal representative; if the participant is under the age of 18 but capable of providing assent, signed assent from the participant.
• • Participant (or caretaker) must be willing to comply with all protocol requirements.
• • Participant must have successfully completed the SD-003 study.
• Exclusion Criteria:
• • Participants who do not meet the inclusion criteria.
• • Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed at the final visit for SD-003 for female participants of childbearing potential.
• • Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.