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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burns (Partial Thickness) | Drug: MEBO Wound Ointment (MEBO) Procedure: Standard practice for partial thickness burns | Phase 2 |
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 |
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
|
- Number of patients having obtained 95% or greater re-epithelialization of target burn at Day 28. [ Time Frame: 28 days of treatment period ]
- Degree of scarring at Day 28 and Day 56. [ Time Frame: 28 days of treatment period plus 28 days of post treatment period ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female between 18 and 65 years of age.
- Capable of giving informed consent.
- Thermal origin burns.
- Patients must be willing to comply with treatment application.
- Capable of understanding and complying with study protocol requirements.
- Study target burn area has had no previous surgical excision.
Exclusion Criteria:
- Chemical or electrical burns.
- Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
- Pregnant or breast-feeding female.
- Known or suspected allergies to any of the components of MEBO.
- Suspicion or presence of active systemic or local cancer or tumor of any kind.
- Any immune deficiency disorder.
- Suspected alcohol or drug abuse.
- Participation in another investigational drug study within 30 days prior to treatment start.

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
Contact: Vicki Christodoulou, M.S., J.D. | 909-587-1650 ext 1682 | vickic@skingenixusa.com |
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 |