Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02014376 | Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa | PHASE2 | COMPLETED | 48 | — | — | Jan 6, 2014 | Jun 24, 2014 | Jan 13, 2020 | 7 | United States |
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
| Arm | Type | Description |
|---|---|---|
| SD-101 Dermal Cream (6%) | EXPERIMENTAL | SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days. |
| SD-101 Dermal Cream (3%) | EXPERIMENTAL | SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days. |
| Vehicle (0%) | PLACEBO_COMPARATOR | Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days. |
| Name | Type | Description |
|---|---|---|
| SD-101 dermal cream (3%) | DRUG | SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients. |
| SD-101 Dermal Cream (6%) | DRUG | SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients. |
| Vehicle (SD-101 0%) | DRUG | A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients. |
Inclusion Criteria: * Informed Consent form signed by the participant or the participant's legal representative; if the participant is under the age of majority but capable of providing assent, signed assent from the participant. * Participant (or caretaker) was willing to comply with all protocol ...