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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Drug, MW-III

Group Type EXPERIMENTAL

Investigational Drug, MW-III

Intervention Type DRUG

Topical application, twice a day

Standard of care

Silvadene® Cream 1% \[Silver Sulfadiazine\]

Group Type ACTIVE_COMPARATOR

Silvadene® Cream 1% [Silver Sulfadiazine]

Intervention Type DRUG

Topical application, twice a day

Interventions

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Investigational Drug, MW-III

Topical application, twice a day

Intervention Type DRUG

Silvadene® Cream 1% [Silver Sulfadiazine]

Topical application, twice a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No