BurnsPhase 2NCT01297400
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
A Phase 2 study testing Investigational Drug, MW-III and Silvadene® Cream 1% [Silver Sulfadiazine] in people with Burns, run by Skingenix, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Investigational Drug, MW-III and Silvadene® Cream 1% [Silver Sulfadiazine]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Mar 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any burn that at screening is:
- infected.
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Recruiting
Valleywise Health Medical Center
Phoenix, Arizona, 85008
- Recruiting
University of CA Davis Medical Center
Sacramento, California, 95817
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Mexico2 sites, 2 recruiting
- Recruiting
Proactive CR Mexico SA de CV
Irapuato
- Recruiting
SMIQ S de R. L de CV
Querétaro City
About this study
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.
Read the detailed description
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.
- Conditions
- Burns
- Being tested
- Investigational Drug, MW-III, Silvadene® Cream 1% [Silver Sulfadiazine]
- Keywords
- Burns, Partial Thickness Burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Drug, MW-IIIDrug
Topical application, twice a day
Silvadene® Cream 1% [Silver Sulfadiazine]Drug
Topical application, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Investigational Drug, MW-III | Experimental | Investigational Drug, MW-III Receives: Drug: Investigational Drug, MW-III |
| Standard of care | Active comparator | Silvadene® Cream 1% [Silver Sulfadiazine] Receives: Drug: Silvadene® Cream 1% [Silver Sulfadiazine] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Measured: 28 days Treatment Period
Secondary outcomes (3)
Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
Measured: 28 days Treatment Period
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Measured: 28 days Treatment Period
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
Measured: 28 days Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study start11 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skingenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Foster, Principal investigator, Valleywise Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297400
- Sponsor's protocol ID
- MW-III-BURN-2-001
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2011
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- ClinicalTrials.gov ID
- NCT01297400
- Acronym / sponsor ID
- MW-III-BURN-2-001
- Conditions
- Burns
- Keywords
- Burns, Partial Thickness Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Skingenix, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Drug, MW-III | Experimental | Drug: Investigational Drug, MW-IIIInvestigational Drug, MW-III |
| Standard of care | Active comparator | Drug: Silvadene® Cream 1% [Silver Sulfadiazine]Silvadene® Cream 1% [Silver Sulfadiazine] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Any burn that at screening is:
- Severe inhalation injury or other significant non-burn trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Drug, MW-IIITopical application, twice a day | Drug | Investigational Drug, MW-III |
| Silvadene® Cream 1% [Silver Sulfadiazine]Topical application, twice a day | Drug | Standard of care |
Primary outcome
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.
3 secondary outcomes
Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
Time frame: 28 days Treatment Period
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Time frame: 28 days Treatment Period
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
Time frame: 28 days Treatment Period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Foster principal investigator
Valleywise Health Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Drug, MW-III and Silvadene® Cream 1% [Silver Sulfadiazine] in people with Burns, run by Skingenix, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicki Christodoulou, MS, JD (909-587-1650, vickic@skingenixusa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (≥95% re-epithelialization) of the partial thickness target burn. (time frame: 28 days Treatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.