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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 March 2013 by Skingenix, Inc.
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01297400
First received: February 14, 2011
Last updated: March 8, 2013
Last verified: March 2013
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
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 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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. One study center located in the United States will participate in this trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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. 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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297400

Contacts
Contact: Vicki Christodoulou, B.S., M.S. 909-587-1650 ext 1682 vickic@skingenixusa.com

Sponsors and Collaborators
Skingenix, Inc.
  More Information

No publications provided

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: March 8, 2013
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 May 16, 2013