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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297400
Recruitment Status : Not yet recruiting
First Posted : February 16, 2011
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.

Brief Summary:
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" in second-degree thermal burns

Condition or disease Intervention/treatment Phase
Burns Drug: MW-III Procedure: Silver Sulfadiazine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Investigational Drug, MW-III
Investigational Drug, MW-III
Drug: MW-III
Topical application, Twice a day

Active Comparator: Standard of care
Silvadene® Cream 1% [Silver Sulfadiazine]
Procedure: Silver Sulfadiazine
Topical Application, Twice a day




Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of subjects with a healed wound. [ Time Frame: 28 days Treatment Period and Follow-up Days 45, 60 and 90. ]
  2. Degree of re-epithelialization (%) at each scheduled study assessment [ Time Frame: 28 days Treatment Period and Follow-up Days 45, 60 and 90. ]
  3. Scar scores at Days 28, 45, 60 and 90 [ Time Frame: 28 days Treatment Period and Follow-up Days 45, 60 and 90. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. In the case of a guardian, guardian must provide informed consent on behalf of the subject.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297400


Contacts
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Contact: Vicki Christodoulou, MS, JD 909-587-1650 ext 1682 vickic@skingenixusa.com

Sponsors and Collaborators
Skingenix, Inc.
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Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01297400    
Other Study ID Numbers: MW-III-BURN-2-001
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Skingenix, Inc.:
Burns, Partial Thickness Burns
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local