Testing a new cream for healing thermal burns

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

This study is testing a new cream for healing partial thickness thermal burns to see if it works better than a standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Skingenix, Inc. (Industry-sponsored)
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT01297400 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with partial thickness thermal burns not exceeding 25% of their total body surface area.

Not a fit: Patients with infected burns, those at high risk for complications, or those requiring immediate surgical intervention will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for healing thermal burns, potentially reducing recovery time for patients.

How similar studies have performed: Other studies have explored topical treatments for burns, but the specific approach of using MW-III is novel and has not been extensively tested.

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.

Where this trial is running

Phoenix, Arizona and 5 other locations

• 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

Conditions Burns; Burns, Partial Thickness Burns