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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns
• Intervention / Treatment: Drug: Investigational Drug, MW-III; Drug: Silvadene® Cream 1% [Silver Sulfadiazine]

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vicki Christodoulou, MS, JD; Phone Number: 1682 909-587-1650; Email: vickic@skingenixusa.com
• Study Contact Backup: Name: Eric Wang, MD; Phone Number: 1678 909-587-1650; Email: ericw@skingenixusa.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Recruiting
      • Valleywise Health Medical Center
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of CA Davis Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Joseph M. Still Burn Center, Doctor's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center New Orleans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.	Time to healing (≥95% re-epithelialization) of the partial thickness target burn.	28 days Treatment Period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Skingenix, Inc.
• Investigators: Principal Investigator: Kevin Foster, Valleywise Health Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): December 22, 2024
• Study Completion (Estimated): December 22, 2024

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimated): February 16, 2011

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Burns, Partial Thickness Burns
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: MW-III-BURN-2-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No