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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.
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Drug, MW-III | Experimental | Investigational Drug, MW-III |
|
| Standard of care | Active Comparator | Silvadene® Cream 1% [Silver Sulfadiazine] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Drug, MW-III | Drug | Topical application, twice a day |
| |
| 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 |
| 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 |
| Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28. |
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Inclusion Criteria:
Exclusion Criteria:
Any burn that at screening is:
Severe inhalation injury or other significant non-burn trauma.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicki Christodoulou, MS, JD | Contact | 909-587-1650 | vickic@skingenixusa.com | |
| Eric Wang, MD | Contact | 909-587-1650 | ericw@skingenixusa.com |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Foster | Valleywise Health Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health Medical Center | Recruiting | Phoenix | Arizona | 85008 | United States | |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
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| Silvadene® Cream 1% [Silver Sulfadiazine] |
| Drug |
Topical application, twice a day |
|
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28. |
| 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 |
| University of CA Davis Medical Center |
| Recruiting |
| Sacramento |
| California |
| 95817 |
| United States |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
| Proactive CR Mexico SA de CV | Recruiting | Irapuato | Mexico |
| SMIQ S de R. L de CV | Recruiting | Querétaro City | Mexico |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |