NCT01297400

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
8mo left

Started Mar 2022

Longer than P75 for phase_2

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2022Dec 2026

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
11.1 years until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

February 14, 2011

Last Update Submit

March 12, 2026

Conditions

Burns

Keywords

Burns, Partial Thickness Burns

Outcome Measures

Primary Outcomes (1)

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

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

    28 days Treatment Period

Secondary Outcomes (3)

  • Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.

    28 days Treatment Period

  • Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.

    28 days Treatment Period

  • Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.

    28 days Treatment Period

Study Arms (2)

Investigational Drug, MW-III

EXPERIMENTAL

Investigational Drug, MW-III

Drug: Investigational Drug, MW-III

Standard of care

ACTIVE COMPARATOR

Silvadene® Cream 1% \[Silver Sulfadiazine\]

Drug: Silvadene® Cream 1% [Silver Sulfadiazine]

Interventions

Investigational Drug, MW-IIIDRUG

Topical application, twice a day

Investigational Drug, MW-III
Silvadene® Cream 1% [Silver Sulfadiazine]DRUG

Topical application, twice a day

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

RECRUITING

University of CA Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Proactive CR Mexico SA de CV

Irapuato, Mexico

RECRUITING

SMIQ S de R. L de CV

Querétaro City, Mexico

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Drugs, InvestigationalSilver Sulfadiazine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsSulfadiazineBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Kevin Foster

    Valleywise Health Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki Christodoulou, MS, JD

CONTACT

909-587-1650vickic@skingenixusa.com

Eric Wang, MD

CONTACT

909-587-1650ericw@skingenixusa.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 16, 2011

Study Start

March 11, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(2)US(4)