NCT01297400PHASE2Recruiting
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Skingenix, Inc.
Start Date
3/11/2022
Completion Date
12/31/2026
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.
Detailed Description
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.
Eligibility Criteria
Age Range: 18 years to No maximum
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, in the judgment of the investigator, at high risk for developing compartment syndrome.
3. partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
2. Severe inhalation injury or other significant non-burn trauma.
Interventions
DRUG
Investigational Drug, MW-III
DRUG
Silvadene® Cream 1% [Silver Sulfadiazine]
Conditions
Burns
Locations
Valleywise Health Medical Center
Phoenix, Arizona 85008
United States
University of CA Davis Medical Center
Sacramento, California 95817
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
University of Iowa Health Care
Iowa City, Iowa 52242
United States
Proactive CR Mexico SA de CV
Irapuato,
Mexico
SMIQ S de R. L de CV
Querétaro City,
Mexico