RecruitingPhase 2

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

United States, Mexico60 participantsStarted 2022-03-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults, 18 years of age or older on the day of signing the informed consent.
✓. 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.
✓. Able and willing to give informed consent and comply with study procedures.

Exclusion criteria

✕. Any burn that at screening is:
✕. infected.
✕. circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
✕. partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
✕. Severe inhalation injury or other significant non-burn trauma.

What they're measuring

Time to healing (≥95% re-epithelialization) of the partial thickness target burn.

Timeframe: 28 days Treatment Period

Trial details

NCT IDNCT01297400

SponsorSkingenix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Vicki Christodoulou, MS, JD

909-587-1650 vickic@skingenixusa.com

View on ClinicalTrials.gov More Burns trials