Burns
Conditions
Keywords
Burns, Partial Thickness Burns
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.
Interventions
DRUGInvestigational Drug, MW-III
Topical application, twice a day
DRUGSilvadene® Cream 1% [Silver Sulfadiazine]
Topical application, twice a day
Sponsors
Skingenix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Mexico, United States
Contacts
CONTACTVicki Christodoulou, MS, JD
CONTACTEric Wang, MD
PRINCIPAL_INVESTIGATORKevin Foster
Valleywise Health Medical Center
Outcome results
None listed