RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-11
Study Completion:2024-12-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01297400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults, 18 years of age or older on the day of signing the informed consent.
  2. 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. 3. Able and willing to give informed consent and comply with study procedures.
  1. 1. Any burn that at screening is:
  2. 1. infected.
  3. 2. circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
  4. 3. partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
  5. 2. Severe inhalation injury or other significant non-burn trauma.

Contacts and Locations

Study Contact

Vicki Christodoulou, MS, JD
CONTACT
909-587-1650
vickic@skingenixusa.com
Eric Wang, MD
CONTACT
909-587-1650
ericw@skingenixusa.com

Principal Investigator

Kevin Foster
PRINCIPAL_INVESTIGATOR
Valleywise Health Medical Center

Study Locations (Sites)

Valleywise Health Medical Center
Phoenix, Arizona, 85008
United States
University of CA Davis Medical Center
Sacramento, California, 95817
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Joseph M. Still Burn Center, Doctor's Hospital
Augusta, Georgia, 30909
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States

Collaborators and Investigators

Sponsor: Skingenix, Inc.

  • Kevin Foster, PRINCIPAL_INVESTIGATOR, Valleywise Health Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-11
Study Completion Date2024-12-22

Study Record Updates

Study Start Date2022-03-11
Study Completion Date2024-12-22

Terms related to this study

Keywords Provided by Researchers

  • Burns, Partial Thickness Burns

Additional Relevant MeSH Terms

  • Burns