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

Phase 2

Recruiting

• Conditions: Burns
• Interventions: Drug: Investigational Drug, MW-III; Drug: Silvadene® Cream 1% [Silver Sulfadiazine]

• Registration Number: NCT01297400
• Lead Sponsor: Skingenix, Inc.

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Study Start: 2022-03-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Drug, MW-III	Investigational Drug, MW-III	Investigational Drug, MW-III
Standard of care	Silvadene® Cream 1% [Silver Sulfadiazine]	Silvadene® Cream 1% \[Silver Sulfadiazine\]

Primary Outcome Measures

Name	Time	Method
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.	28 days Treatment Period	Time to healing (≥95% re-epithelialization) of the partial thickness target burn.

Secondary Outcome Measures

Name	Time	Method
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 that are healed at each scheduled study assessment.
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.	28 days Treatment Period	Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.	28 days Treatment Period	Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.

Trial Locations

Locations (4)

Valleywise Health Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of CA Davis Medical Center; 🇺🇸 Sacramento, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Joseph M. Still Burn Center, Doctor's Hospital; 🇺🇸 Augusta, Georgia, United States