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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297400
• Other study ID #: MW-III-BURN-2-001
• Status: Recruiting
• Phase: Phase 2
• Start date: March 11, 2022
• Est. completion date: December 22, 2024

Study information

• Verified date: February 2024
• Source: Skingenix, Inc.
• Contact: Vicki Christodoulou, MS, JD
• Phone: 909-587-1650
• Email: vickic[@]skingenixusa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 22, 2024
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Investigational Drug, MW-III
Topical application, twice a day
• Silvadene® Cream 1% [Silver Sulfadiazine]
Topical application, twice a day

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center, Doctor's Hospital	Augusta	Georgia
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Skingenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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