Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dermacyn · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Topical Dermacyn |
| 2 | ACTIVE_COMPARATOR | Topical Dermacyn and levofloxacin |
| 3 | ACTIVE_COMPARATOR | Topical saline and levofloxacin |
| Name | Type | Description |
|---|---|---|
| Topical Dermacyn | DRUG | Topical Dermacyn once a day for 10 Days |
| Topical Dermacyn and Levofloxacin | DRUG | Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days |
| Topical Saline and Levofloxacin | DRUG | Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days |
Inclusion Criteria: * A patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Males and females \> 18 years of age with diabetes mellitus (type 1 or type 2, controlled). 2. Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper ...
Dermacyn is an investigational small molecule being studied for the treatment of diabetic foot ulcers. It is a topical wound care product evaluated in a Phase 2 clinical trial for mild diabetic foot infections. The drug is not approved and remains in clinical development.
Dermacyn is being developed by Sonoma Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker SNOA. The company is conducting clinical research to evaluate the safety and efficacy of this topical wound care product for diabetic foot ulcers.
Dermacyn is in Phase 2 clinical development. A Phase 2 pilot study has been completed, evaluating the safety and clinical efficacy of topical Dermacyn wound care for mild diabetic foot infections. The drug is investigational and not yet approved for commercial use.
Dermacyn has one completed clinical trial, NCT00516958, a Phase 2 pilot study of the safety and clinical efficacy of topical Dermacyn wound care to treat mild diabetic foot infections. The trial enrolled 65 participants in the United States and was active-controlled.
Dermacyn is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for diabetic foot ulcers. The drug remains in clinical development and has not received regulatory approval for any indication.