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

Skingenix

Status and phase: Enrolling; Phase 2

Conditions: Burns

Treatments: Drug: Investigational Drug, MW-III; Drug: Silvadene® Cream 1% [Silver Sulfadiazine]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01297400

MW-III-BURN-2-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Investigational Drug, MW-III

Experimental group

Description:

Investigational Drug, MW-III

Treatment:

Drug: Investigational Drug, MW-III

Standard of care

Active Comparator group

Description:

Silvadene® Cream 1% \[Silver Sulfadiazine\]

Treatment:

Drug: Silvadene® Cream 1% [Silver Sulfadiazine]