NCT01297400RecruitingPhase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Skingenix, Inc.
- Enrollment
- 60
- Locations
- 9
- Primary Endpoint
- Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults, 18 years of age or older on the day of signing the informed consent.
- •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.
- •Able and willing to give informed consent and comply with study procedures.
Exclusion Criteria
- •Any burn that at screening is:
- •circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
- •partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
- •Severe inhalation injury or other significant non-burn trauma.
Arms & Interventions
Investigational Drug, MW-III
Experimental
Investigational Drug, MW-III
Intervention: Investigational Drug, MW-III (Drug)
Standard of care
Active Comparator
Silvadene® Cream 1% [Silver Sulfadiazine]
Intervention: Silvadene® Cream 1% [Silver Sulfadiazine] (Drug)
Outcomes
Primary Outcomes
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Time Frame: 28 days Treatment Period
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Secondary Outcomes
- 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.(28 days Treatment Period)
- Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.(28 days Treatment Period)
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Completed
Phase 3
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis BullosaEpidermolysis BullosaNCT02384460Scioderm, Inc.169
Withdrawn
Phase 3
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins TreatmentVARICOSE VEINSNCT01426035EMS
Completed
Phase 3
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial VaginosisBacterial VaginosisNCT01577537Starpharma Pty Ltd251
Completed
Phase 3
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial VaginosisBacterial VaginosisNCT01577238Starpharma Pty Ltd250
Completed
Phase 3
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)Bacterial VaginosisNCT02236156Starpharma Pty Ltd637