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NCT Number: NCT01297400

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Proactive CR Mexico SA de CV, Irapuato, Mexico

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About this study

This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Investigational Drug, MW-III

Drug

Topical application, twice a day

Silvadene® Cream 1% [Silver Sulfadiazine]

Drug

Topical application, twice a day

Primary outcomes

  1. 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

  1. 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 that are healed at each scheduled study assessment.

  2. 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

    Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.

  3. Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Wang, MD

CONTACT

[email protected]

909-587-1650

Vicki Christodoulou, MS, JD

CONTACT

[email protected]

909-587-1650

Sponsors and collaborators

Lead sponsor

Skingenix, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2011
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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