Approval Probability
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Adjusted LOA
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SD-101 dermal · 1 trial · 1 indication
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 ...
SD-101 dermal is an investigational small molecule being studied for the treatment of Epidermolysis Bullosa, a rare genetic skin disorder. It is applied to the skin and is currently in Phase 2 clinical development. The drug has completed one clinical trial in the United States.
SD-101 dermal is being developed by Amicus Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol FOLD. The company is conducting clinical research on this investigational therapy for Epidermolysis Bullosa.
SD-101 dermal is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 2 clinical trial for the treatment of Epidermolysis Bullosa has been completed.
SD-101 dermal has one completed clinical trial, identified as NCT02014376, titled "Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa." This Phase 2 study enrolled 48 participants in the United States and was randomized, double-blind, and placebo-controlled.
SD-101 dermal is a specific formulation of the drug SD-101, developed by Amicus Therapeutics for topical application in treating Epidermolysis Bullosa. The clinical trial NCT02014376 evaluated this dermal formulation in patients with the condition.