Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

Skingenix, Inc.

Summary

To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Description

This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Adults, 18 years of age or older on the day of signing the informed consent. 2. Thermal Burns not exceeding a total body surface area (TBSA) OF 25%, with at least one partial thickness burn of 0.5% TBSA or greater. If full thickness burn(s) are present at screening, the total full thickness burn area shall not exceed 10% TBSA. Note: TBSA excludes areas of superficial (first degree) burns. 3. Able and willing to give informed consent and comply with study procedures. Exclusion Criteria: 1. Any burn that at screening is: 1. infected. 2. circumferential or deemed,…

Interventions

Drug
Investigational Drug, MW-III
Topical application, twice a day
Drug
Silvadene® Cream 1% [Silver Sulfadiazine]
Topical application, twice a day

Locations (6)

Valleywise Health Medical Center
Phoenix, Arizona
University of CA Davis Medical Center
Sacramento, California
MedStar Washington Hospital Center
Washington D.C., District of Columbia
University of Iowa Health Care
Iowa City, Iowa
Proactive CR Mexico SA de CV
Irapuato
SMIQ S de R. L de CV
Querétaro City