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

Launched by SKINGENIX, INC. · Feb 15, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MW-III for patients with thermal burns. The goal is to see if MW-III can help these burns heal faster compared to a standard treatment called Silvadene® Cream, which is commonly used for burns. The focus is on how quickly the skin can heal, specifically looking for at least 95% of the burn area to be healed.

To participate in this study, you need to be an adult aged 18 or older with certain types of burns. Specifically, you should have partial thickness burns that cover a small area of your body and are not infected or at high risk for complications. If you join the study, you will be closely monitored as you receive either MW-III or Silvadene® Cream, and your healing progress will be tracked. This trial is open to all genders and is currently recruiting participants, so if you or a loved one are interested, it could be a way to access new treatment options while contributing to important research.

Gender

ALL

Eligibility 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, 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.