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A Phase 2, Open Label, Randomized, Active-Controlled Pilot Study MW-III vs Silver Sulfadiazine Second Degree Thermal Burns

Primary Purpose

Burns

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Investigational Drug, MW-III
Silvadene® Cream 1% [Silver Sulfadiazine]
Sponsored by
Skingenix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Partial Thickness Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults (≥18 years of age) on the day of signing the informed consent
  2. Diagnosed with a single second-degree thermal burn
  3. Burn occurrence ≤24 hours prior to study entry
  4. Able and willing to give informed consent and comply with study procedures.

Exclusion Criteria:

  1. Patients with the co-existence of full thickness (third-degree) burn wound
  2. Multiple second-degree thermal burns
  3. Circumferential burns or burns deemed high risk for developing compartment syndrome
  4. Target burn wound requiring surgical intervention, such as excision/grafting

Sites / Locations

  • Valleywise Health Medical CenterRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Joseph M. Still Burn Center, Doctor's HospitalRecruiting
  • University Medical Center New OrleansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Drug, MW-III

Standard of care

Arm Description

Investigational Drug, MW-III

Silvadene® Cream 1% [Silver Sulfadiazine]

Outcomes

Primary Outcome Measures

Time to healing, with a healed wound (wound healing) defined as ≥95% re-epithelialization of the target wound

Secondary Outcome Measures

Degree of re-epithelialization (%) at each scheduled study assessment
Proportion of subjects determined to require excision/grafting of burn wound by Day 28
Scar scores at Days 28, 45, 60 and 90
Proportion of subjects with a healed wound by each scheduled study assessment

Full Information

First Posted
February 14, 2011
Last Updated
April 10, 2023
Sponsor
Skingenix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01297400
Brief Title
A Phase 2, Open Label, Randomized, Active-Controlled Pilot Study MW-III vs Silver Sulfadiazine Second Degree Thermal Burns
Official Title
A Phase 2, Open-Label, Randomized, Active-Controlled Pilot Study of Investigational Drug, MW-III Versus Silvadene® Cream 1% (Silver Sulfadiazine) Topically Applied to Second-Degree Thermal Burns in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
March 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skingenix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" in second-degree thermal burns
Detailed Description
This is an open-label, randomized, active-controlled pilot study to evaluate the efficacy and safety profile of topical MW-III versus an active control (Silvadene® Cream 1% [Silver Sulfadiazine]) in the treatment of second-degree thermal burns in adults. Approximately 30 subjects per treatment group will be enrolled and 60 subjects in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns, Partial Thickness Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Drug, MW-III
Arm Type
Experimental
Arm Description
Investigational Drug, MW-III
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Silvadene® Cream 1% [Silver Sulfadiazine]
Intervention Type
Drug
Intervention Name(s)
Investigational Drug, MW-III
Intervention Description
Topical application, twice a day
Intervention Type
Drug
Intervention Name(s)
Silvadene® Cream 1% [Silver Sulfadiazine]
Intervention Description
Topical application, twice a day
Primary Outcome Measure Information:
Title
Time to healing, with a healed wound (wound healing) defined as ≥95% re-epithelialization of the target wound
Time Frame
28 days Treatment Period
Secondary Outcome Measure Information:
Title
Degree of re-epithelialization (%) at each scheduled study assessment
Time Frame
28 days Treatment Period and Follow-up Days 45, 60 and 90
Title
Proportion of subjects determined to require excision/grafting of burn wound by Day 28
Time Frame
28 days Treatment Period and Follow-up Days 45, 60 and 90
Title
Scar scores at Days 28, 45, 60 and 90
Time Frame
28 days Treatment Period and Follow-up Days 45, 60 and 90
Title
Proportion of subjects with a healed wound by each scheduled study assessment
Time Frame
28 days Treatment Period and Follow-up Days 45, 60 and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (≥18 years of age) on the day of signing the informed consent Diagnosed with a single second-degree thermal burn Burn occurrence ≤24 hours prior to study entry Able and willing to give informed consent and comply with study procedures. Exclusion Criteria: Patients with the co-existence of full thickness (third-degree) burn wound Multiple second-degree thermal burns Circumferential burns or burns deemed high risk for developing compartment syndrome Target burn wound requiring surgical intervention, such as excision/grafting
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicki Christodoulou, MS, JD
Phone
909-587-1650
Ext
1682
Email
vickic@skingenixusa.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Wang, MD
Phone
909-587-1650
Ext
1678
Email
ericw@skingenixusa.com
Facility Information:
Facility Name
Valleywise Health Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Joseph M. Still Burn Center, Doctor's Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2, Open Label, Randomized, Active-Controlled Pilot Study MW-III vs Silver Sulfadiazine Second Degree Thermal Burns

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