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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
Must not have
Any burn that at screening is infected
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days treatment period
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My burn wound is infected.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Secondary study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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% \[Silver Sulfadiazine\]

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
~0 spots leftby Dec 2024
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