| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02384460 | ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa | PHASE3 | COMPLETED | 169 | — | — | Mar 11, 2015 | Jul 5, 2017 | Apr 9, 2020 | 38 | United States, Australia +11 |
Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Time to target wound closure was measured from the date of the first administration of the study drug to the date of target wound closure. Participants were censored if they did not have a response within 3 months, or withdrew earlier before the confirmation of their target wound closing. This primary end point displays the mean time to complete target wound closure, analyzed using a Kaplan-Meier approach.
Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Participants were considered responders if they experienced complete wound closure at the Week 2 or Months 1, 2, or 3 visits. If a target wound was documented to have closed at a given visit, it was considered closed at all subsequent visits. This primary end point displays the percentage of participants from the ITT population who had complete target wound closure by the end of the study period (that is, 3 months). Analysis was performed on participants with post-baseline wound closure data.
| Arm | Type | Description |
|---|---|---|
| SD-101-6.0 cream | EXPERIMENTAL | SD-101-6.0 cream applied topically, once a day to the entire body for a period of 90 days |
| Placebo (SD-101-0.0) cream | PLACEBO_COMPARATOR | SD-101-0.0 (placebo) cream applied topically, once a day to the entire body for a period of 90 days |
| Name | Type | Description |
|---|---|---|
| SD-101-6.0 cream | DRUG | applied topically once a day for 90 days |
| Placebo (SD-101-0.0) cream | DRUG | applied topically once a day for 90 days |
Inclusion Criteria: * Informed Consent form signed by the participant or participant's legal representative; if the participant was under the age of 18 but capable of providing assent, signed assent from the participant. * Participant (or caretaker) must have been willing to comply with all protoco...