Participants in the study ranged in age from 6 months to 43 years old. Eligible patients were randomized to 1 of 3 dose concentration groups (SD‑101‑3.0, SD-101-6.0 or SD-101-0.0 (placebo)) and applied SD‑101 topically once per day to the entire body for 90 days. SD‑101 was applied in conjunction with the patient’s standard of care. Closure of chronic wounds, reduction in body coverage of lesional skin, change in itching, and the safety profile of SD-101 were the primary factors under investigation in the Phase 2 clinical trial. All patients who completed the study were eligible to receive active therapy.
- SD-101-6.0 was the most efficacious dose and is being used in the ongoing Phase 3 study (SD-005).
- SD-101-6.0 stimulated faster and greater wound closure relative to both placebo treatment and treatment with SD-101-3.0.
- Daily use of the SD-101-6.0 was well tolerated with no safety issues of any concern.
Phase 2 Open Label Extension Study (SD-004)
All patients that completed the SD-003 study were eligible to continue to receive active therapy in an open label extension study (SD-004). Ninety-five (95%) of patients completing the SD-003 study enrolled in this study.