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Dermacyn

Phase 2

Foot Ulcer, Diabetic | Small molecule | Metabolic |Sonoma Pharmaceuticals, Inc.|Trials Updated: Jan 14, 2008

Target and mechanism

ModalitySmall molecule

Also known as Topical Dermacyn

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

Dermacyn · 1 trial · 1 indication

Phase 2 1
NCT00516958Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot InfectionsFoot Ulcer, Diabetic
COMPLETED65 Analytics
PHASE2COMPLETED
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
Foot Ulcer, DiabeticUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
Visit 3 (Day 10); Visit 4 (Day 24)

Secondary Endpoints

To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes
Visit 2 (Day 3); Visit 3 (Day 10)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTopical Dermacyn
2ACTIVE_COMPARATORTopical Dermacyn and levofloxacin
3ACTIVE_COMPARATORTopical saline and levofloxacin

Interventions

NameTypeDescription
Topical DermacynDRUGTopical Dermacyn once a day for 10 Days
Topical Dermacyn and LevofloxacinDRUGTopical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
Topical Saline and LevofloxacinDRUGTopical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 ...

Countries:United States
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Frequently asked questions about Dermacyn

What is Dermacyn used for?

Dermacyn is a topical wound care product being studied for the treatment of mild diabetic foot infections and diabetic foot ulcers. It is applied directly to the wound area. Sonoma Pharmaceuticals, Inc. is developing it as a small molecule therapy in the metabolic therapeutic area.

Who makes Dermacyn?

Dermacyn is developed by Sonoma Pharmaceuticals, Inc., which trades under the ticker SNOA. The company is the sponsor behind the clinical development program for this topical wound care product.

What phase is Dermacyn in?

Dermacyn is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 program consists of one completed trial evaluating its use in diabetic foot infections.

What clinical trials is Dermacyn in?

Dermacyn has been evaluated in one Phase 2 trial, NCT00516958, titled a 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 is completed.

Is Dermacyn the same as Topical Dermacyn?

Yes, Dermacyn is also known as Topical Dermacyn. The two names refer to the same wound care product developed by Sonoma Pharmaceuticals, Inc. for diabetic foot infections and foot ulcers.

How was the Dermacyn Phase 2 trial designed?

The Phase 2 trial NCT00516958 was a randomized, active-controlled study that enrolled 65 participants aged 18 years and older of all sexes. It was not double-blind and did not use biomarker selection. The study evaluated topical Dermacyn wound care for mild diabetic foot infections.