Testing a new cream for healing thermal burns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 pilot study aims to evaluate the safety and effectiveness of a topical treatment called MW-III compared to Silvadene® Cream 1% in patients with partial thickness thermal burns. The primary focus is on measuring the time it takes for the burns to heal, specifically looking for at least 95% re-epithelialization. Participants will be adults with specific criteria regarding the size and type of their burns, and the study will monitor their healing progress over time.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Kevin Foster — Valleywise Health Medical Center
• Study coordinator: Vicki Christodoulou, MS, JD
• Email: vickic@skingenixusa.com
• Phone: 909-587-1650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.