Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Purpose
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.
Condition
- Burns
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Investigational Drug, MW-III |
Investigational Drug, MW-III |
|
|
Active Comparator Standard of care |
Silvadene® Cream 1% [Silver Sulfadiazine] |
|
Recruiting Locations
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Skingenix, Inc.
Detailed Description
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.