Back to Trials
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]

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

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