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

RecruitingPhase 2Ages 18 Years - anyAllSkingenix, Inc.
NCT01297400 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Investigational Drug, MW-III
  • Silvadene® Cream 1% [Silver Sulfadiazine]
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Where

6 sites
Valleywise Health Medical Center
Phoenix, United States
University of CA Davis Medical Center
Sacramento, United States
MedStar Washington Hospital Center
Washington D.C., United States
University of Iowa Health Care
Iowa City, United States
Proactive CR Mexico SA de CV
Irapuato, Mexico
SMIQ S de R. L de CV
Querétaro City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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