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. (see Contacts and Locations)

Verified April 2016 by Skingenix, Inc.

Sponsor:

Information provided by (Responsible Party):

Skingenix, Inc.

ClinicalTrials.gov Identifier:

NCT01297400

First received: February 14, 2011

Last updated: April 13, 2016

Last verified: April 2016

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Burns Wounds and Injuries

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	14
Study Start Date:	September 2016
Estimated Study Completion Date:	July 2017
Estimated Primary Completion Date:	July 2017 (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)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

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 13, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Skingenix, Inc.:


Burns, Partial Thickness Burns

Additional relevant MeSH terms:


Burns Wounds and Injuries

ClinicalTrials.gov processed this record on September 28, 2016

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