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A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns
This study is not yet open for participant recruitment.
Verified April 2017 by Skingenix, Inc.
Sponsor:
Skingenix, Inc.
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01297400
First received: February 14, 2011
Last updated: April 24, 2017
Last verified: April 2017
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Purpose
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with partial thickness burns.
| Condition | Intervention | Phase |
|---|---|---|
| Burns (Partial Thickness) | Drug: MEBO Wound Ointment (MEBO) Procedure: Standard practice for partial thickness burns | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Skingenix, Inc.:
Primary Outcome Measures:
- 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:
- Degree of scarring at Day 28 and Day 56. [ Time Frame: 28 days of treatment period plus 28 days of post treatment period ]
| Estimated Enrollment: | 14 |
| Anticipated Study Start Date: | January 2, 2018 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297400
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297400
Contacts
| Contact: Vicki Christodoulou, M.S., J.D. | 909-587-1650 ext 1682 | vickic@skingenixusa.com |
Sponsors and Collaborators
Skingenix, Inc.
More Information
| Responsible Party: | Skingenix, Inc. |
| ClinicalTrials.gov Identifier: | NCT01297400 History of Changes |
| Other Study ID Numbers: |
MEBO-BPII-001 v1.2 |
| Study First Received: | February 14, 2011 |
| Last Updated: | April 24, 2017 |
| 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 |
ClinicalTrials.gov processed this record on August 18, 2017