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Clinical Trials in the USA / NCT01297400
Recruiting Phase 2

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

NCT01297400 · tracked via the Priya Life Science USA tracker
Sponsor
Skingenix, Inc
Phase
Phase 2
Started
2022-03-11
Last updated
2026-03-16

Condition(s) studied

Burns

Investigational drug(s) / intervention(s)

Investigational Drug, MW-IIISilvadene® Cream 1% [Silver Sulfadiazine]

Investigational Drug, MW-III: Topical application, twice a day

Silvadene® Cream 1% [Silver Sulfadiazine]: Topical application, twice a day

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time to healing (≥95% re-epithelialization) of the partial thickness target burn. — 28 days Treatment Period
    Time to healing (≥95% re-epithelialization) of the partial thickness target burn.

Trial sites (6)

FacilityCityRegionStatus
Valleywise Health Medical Center Phoenix Arizona Recruiting
University of CA Davis Medical Center Sacramento California Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
University of Iowa Health Care Iowa City Iowa Recruiting
Proactive CR Mexico SA de CV Irapuato Mexico Recruiting
SMIQ S de R. L de CV Querétaro City Mexico Recruiting

Other trials for the same condition

Clinical Registry Collecting Real World Evidence on Wound Care Treatments Enrolling by invitation
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns Active, not recruiting
Microsurfaced Grafts in Deep Burn Wounds Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01297400 on ClinicalTrials.gov ↗ ← All trials in the USA