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MW-III vs Silver Sulfadiazine for Burns

Phase 2

Recruiting

Led By Kevin Foster

Research Sponsored by Skingenix, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days treatment period

Awards & highlights

Study Summary

This trial compares the time it takes for MW-III to heal second-degree thermal burns versus Silvadene® Cream 1%.

Who is the study for?

This trial is for adults (18+) who have a single second-degree thermal burn that happened within the last 24 hours. They must be able to consent and follow study procedures. People with multiple burns, third-degree burns, burns needing surgery, or at high risk of compartment syndrome can't join.Check my eligibility

What is being tested?

The study aims to see if MW-III works faster than Silvadene Cream (Silver Sulfadiazine) in healing second-degree thermal burns. Participants will randomly receive either the investigational drug MW-III or the standard treatment with Silvadene.See study design

What are the potential side effects?

While specific side effects for MW-III are not listed here, Silver Sulfadiazine may cause skin discoloration, burning sensation on application, rash or itching; more serious but rare effects include blood disorders or liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My burns cover less than 25% of my body and include at least one serious burn.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Drug, MW-IIIExperimental Treatment1 Intervention

Investigational Drug, MW-III

Group II: Standard of careActive Control1 Intervention

Silvadene® Cream 1% [Silver Sulfadiazine]

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Skingenix, Inc.Lead Sponsor

3 Previous Clinical Trials

87 Total Patients Enrolled

Kevin FosterPrincipal InvestigatorValleywise Health Medical Center

Media Library

MW-III Clinical Trial Eligibility Overview. Trial Name: NCT01297400 — Phase 2

Burns Research Study Groups: Investigational Drug, MW-III, Standard of care

Burns Clinical Trial 2023: MW-III Highlights & Side Effects. Trial Name: NCT01297400 — Phase 2

MW-III 2023 Treatment Timeline for Medical Study. Trial Name: NCT01297400 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might there be any harmful consequences to taking MW-III?

"Because this is a phase 2 trial, there is only some data supporting safety for the Investigational Drug, MW-III. The Power team gave it a score of 2."

Answered by AI

Are people of all ages welcome in this clinical trial?

"The age range for this clinical trial is 18-65 years old."

Answered by AI

In how many areas is this research project being conducted?

"The trial is being conducted at Valleywise Health Medical Center in Phoenix, Arizona; University Medical Center New Orleans in New Orleans, Louisiana; MedStar Washington Hospital Center in Washington, District of Columbia and other medical facilities."

Answered by AI

How many individuals are part of this investigation?

"Sixty volunteers are necessary to enroll in this trial. The individuals must meet the pre-determined inclusion criteria and can be recruited from Valleywise Health Medical Center in Phoenix, Arizona or University Medical Center New Orleans in New Orleans, Louisiana."

Answered by AI

Which patients would be best-suited for this particular clinical trial?

"Sixty individuals, aged 18-65 who have experienced burns within the last 24 hours, are being accepted into this study."

Answered by AI

Are there any current openings for volunteers in this experimental procedure?

"Correct, this research is currently looking for volunteers. The information on clinicaltrials.gov shows that the original posting was on March 11th, 2022 and the last update was September 20th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01297400.

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