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A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns

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ClinicalTrials.gov Identifier: NCT01297400
Recruitment Status : Not yet recruiting
First Posted : February 16, 2011
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with partial thickness burns.

Condition or disease Intervention/treatment Phase
Burns (Partial Thickness) Drug: MEBO Wound Ointment (MEBO) Procedure: Standard practice for partial thickness burns Phase 2

Detailed Description:
MEBO-BPII-001 is a single-center, randomized, standard care-controlled pilot study of topically applied MEBO in subjects with partial thickness burns expected to heal in 14 days. Twice daily application of MEBO versus standard of care will be evaluated in a parallel design. Fourteen subjects will be randomized (7 subjects per treatment arm) to one of two treatment groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Controlled, Single-Center Pilot Study of the Efficacy and Safety of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Partial Thickness Burns
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: MEBO Wound Ointment (MEBO) Drug: MEBO Wound Ointment (MEBO)
Topical application twice a day
Active Comparator: Standard of care Procedure: Standard practice for partial thickness burns
Daily application of collagenase ointment with polysporin powder and covered with gauze dressings


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients having obtained 95% or greater re-epithelialization of target burn at Day 28. [ Time Frame: 28 days of treatment period ]

Secondary Outcome Measures :
  1. Degree of scarring at Day 28 and Day 56. [ Time Frame: 28 days of treatment period plus 28 days of post treatment period ]

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

Inclusion Criteria:

  1. Male or female between 18 and 65 years of age.
  2. Capable of giving informed consent.
  3. Thermal origin burns.
  4. Patients must be willing to comply with treatment application.
  5. Capable of understanding and complying with study protocol requirements.
  6. Study target burn area has had no previous surgical excision.

Exclusion Criteria:

  1. Chemical or electrical burns.
  2. Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
  3. Pregnant or breast-feeding female.
  4. Known or suspected allergies to any of the components of MEBO.
  5. Suspicion or presence of active systemic or local cancer or tumor of any kind.
  6. Any immune deficiency disorder.
  7. Suspected alcohol or drug abuse.
  8. Participation in another investigational drug study within 30 days prior to treatment start.
Contacts and Locations
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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
Contact: Vicki Christodoulou, M.S., J.D. 909-587-1650 ext 1682 vickic@skingenixusa.com

Sponsors and Collaborators
Skingenix, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01297400     History of Changes
Other Study ID Numbers: MEBO-BPII-001 v1.2
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Burns
Wounds and Injuries