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 August 2013 by Skingenix, Inc.
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01297400
First received: February 14, 2011
Last updated: August 28, 2013
Last verified: August 2013

February 14, 2011
August 28, 2013
September 2013
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01297400 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns (Partial Thickness)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
14
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female between 18 and 65 years of age.
  2. Capable of giving informed consent.
  3. Thermal origin burns.
  4. Patients must be willing to comply with treatment application.
  5. Capable of understanding and complying with study protocol requirements.
  6. Study target burn area has had no previous surgical excision.

Exclusion Criteria:

  1. Chemical or electrical burns.
  2. Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
  3. Pregnant or breast-feeding female.
  4. Known or suspected allergies to any of the components of MEBO.
  5. Suspicion or presence of active systemic or local cancer or tumor of any kind.
  6. Any immune deficiency disorder.
  7. Suspected alcohol or drug abuse.
  8. Participation in another investigational drug study within 30 days prior to treatment start.
Both
18 Years to 65 Years
No
Contact: Vicki Christodoulou, B.S., M.S. 909-587-1650 ext 1682 vickic@skingenixusa.com
Not Provided
 
NCT01297400
MEBO-BPII-001 v1.2
Not Provided
Skingenix, Inc.
Skingenix, Inc.
Not Provided
Not Provided
Skingenix, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP