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Also known as SD-101 dermal cream (3%)
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 condition. It is a topical cream formulation applied to the skin. Amicus Therapeutics is developing it as a potential therapy for this rare disease.
SD-101 dermal is being developed by Amicus Therapeutics, Inc., which trades on the Nasdaq under the ticker FOLD. The company is the sponsor of the clinical program evaluating this topical cream for epidermolysis bullosa.
SD-101 dermal is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational therapy. One Phase 2 trial has been completed, and no trials are currently active.
SD-101 dermal has been evaluated in one completed Phase 2 trial, NCT02014376, titled Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa. The trial enrolled 48 participants in the United States, included patients as young as 6 months, and was randomized, double-blind, and placebo-controlled.
Yes, SD-101 dermal cream (3%) is another name for SD-101 dermal. Both refer to the same topical small molecule cream developed by Amicus Therapeutics for epidermolysis bullosa, so searches using either name point to the same investigational asset.