A Phase 2, Open Label, Randomized, Active-Controlled Pilot Study MW-III vs Silver Sulfadiazine Second Degree Thermal Burns

Study Overview
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Brief Summary
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To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to time to healing in second-degree thermal burns

Detailed Description
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This is an open-label, randomized, active-controlled pilot study to evaluate the efficacy and safety profile of topical MW-III versus an active control (Silvadene® Cream 1% [Silver Sulfadiazine]) in the treatment of second-degree thermal burns in adults. Approximately 30 subjects per treatment group will be enrolled and 60 subjects in total.

Official Title
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A Phase 2, Open-Label, Randomized, Active-Controlled Pilot Study of Investigational Drug, MW-III Versus Silvadene® Cream 1% (Silver Sulfadiazine) Topically Applied to Second-Degree Thermal Burns in Adults

Conditions
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Burns

Intervention / Treatment
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* Drug: Investigational Drug, MW-III
* Drug: Silvadene® Cream 1% [Silver Sulfadiazine]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years of age) on the day of signing the informed consent Diagnosed with a single second-degree thermal burn Burn occurrence ≤24 hours prior to study entry Able and willing to give informed consent and comply with study procedures. Exclusion Criteria: Patients with the co-existence of full thickness (third-degree) burn wound Multiple second-degree thermal burns Circumferential burns or burns deemed high risk for developing compartment syndrome Target burn wound requiring surgical intervention, such as excision/grafting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Drug, MW-III<br>Investigational Drug, MW-III | Drug: Investigational Drug, MW-III<br>* Topical application, twice a day<br>|
| Active Comparator: Standard of care<br>Silvadene® Cream 1% [Silver Sulfadiazine] | Drug: Silvadene® Cream 1% [Silver Sulfadiazine]<br>* Topical application, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing, with a healed wound (wound healing) defined as ≥95% re-epithelialization of the target wound |  | 28 days Treatment Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of re-epithelialization (%) at each scheduled study assessment |  | 28 days Treatment Period and Follow-up Days 45, 60 and 90 | 
| Proportion of subjects determined to require excision/grafting of burn wound by Day 28 |  | 28 days Treatment Period and Follow-up Days 45, 60 and 90 | 
| Scar scores at Days 28, 45, 60 and 90 |  | 28 days Treatment Period and Follow-up Days 45, 60 and 90 | 
| Proportion of subjects with a healed wound by each scheduled study assessment |  | 28 days Treatment Period and Follow-up Days 45, 60 and 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Partial Thickness Burns