Recruiting
Phase 2

MW-III

Sponsor:

Skingenix, Inc.

Code:

NCT01297400

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Investigational Drug, MW-III

Silvadene® Cream 1% [Silver Sulfadiazine]

Study Details

Brief 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.

Conditions

Burns

Study ID

NCT01297400

Start date

Mar 11, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Investigational Drug, MW-III

Investigational Drug, MW-III

active comparator: Standard of care

Silvadene® Cream 1% \[Silver Sulfadiazine\]

Interventions

Investigational Drug, MW-III

Topical application, twice a day

Silvadene® Cream 1% [Silver Sulfadiazine]

Topical application, twice a day

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vicki Christodoulou, MS, JD

909-587-1650vickic@skingenixusa.com

Eric Wang, MD

909-587-1650ericw@skingenixusa.com

Locations

Valleywise Health Medical Center

Recruiting

Phoenix, Arizona, United States, 85008

University of CA Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

Skingenix, Inc.

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Burns, Partial Thickness Burns

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Skingenix, Inc. on 2026-03-16.