NCT01297400 Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
| NCT ID | NCT01297400 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Skingenix, Inc. |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-03-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2022-03-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kevin Foster
PRINCIPAL INVESTIGATOR
Valleywise Health Medical Center
Frequently Asked Questions
Who can join the NCT01297400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01297400 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT01297400 currently recruiting?
Yes, NCT01297400 is actively recruiting participants. Contact the research team at vickic@skingenixusa.com for enrollment information.
Where is the NCT01297400 trial being conducted?
This trial is being conducted at Phoenix, United States, Sacramento, United States, Washington D.C., United States, Iowa City, United States and 2 additional locations.
Who is sponsoring the NCT01297400 clinical trial?
NCT01297400 is sponsored by Skingenix, Inc.. The principal investigator is Kevin Foster at Valleywise Health Medical Center. The trial plans to enroll 60 participants.