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

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

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. One study center located in the United States will participate in this trial.

• Drug: MEBO Wound Ointment (MEBO)
  Topical application twice a day
• Procedure: Standard practice for partial thickness burns
  Daily application of collagenase ointment with polysporin powder and covered with gauze dressings

• Experimental: MEBO Wound Ointment (MEBO)
  Intervention: Drug: MEBO Wound Ointment (MEBO)
• Active Comparator: Standard of care
  Intervention: Procedure: Standard practice for partial thickness burns

Inclusion Criteria:

1. Male or female between 18 and 65 years of age.
2. Capable of giving informed consent.
3. Female of childbearing potential with a negative result from pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial.
4. Thermal origin burns.
5. Total burn area for all burns on a single patient should be no greater than 10% of Total Body Surface Area (TBSA).
6. Study target burn should be less than 24 hours post burn.
7. Study target burn area is determined to be partial thickness burns expected to heal in 14 days.
8. Individual study target burn size should be no greater than 1% TBSA.
9. Total study target burn area should be no greater than 200 cm2 or 1% TBSA.
10. Patients must be willing to comply with treatment application.
11. Capable of understanding and complying with study protocol requirements.
12. Study target burn area has had no previous surgical excision.

Exclusion Criteria:

1. Chemical or electrical burns.
2. Deep partial thickness burns requiring split thickness skin grafting (STSG).
3. Target burn is at the knee, over any joint, or on the hand, genitalia or face.
4. Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
5. Pregnant or breast-feeding female.
6. Known or suspected allergies to any of the components of MEBO.
7. Hypoalbuminemia (prealbumin < 18 mg/dL or serum albumin <2.5 g/dL) at screening.
8. Overtly infected target burn (as judged by investigator on clinical wound examination).
9. Suspicion or presence of active systemic or local cancer or tumor of any kind.
10. Any immune deficiency disorder.
11. Known clinically significant organ or systemic diseases, such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study (e.g., severe retinopathy requiring laser therapy, terminal kidney disease etc.)
12. Suspected alcohol or drug abuse.

13. Participation in another investigational drug study within 30 days prior to treatment start.

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