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

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ClinicalTrials.gov Identifier: NCT01297400
Recruitment Status : Not yet recruiting
First Posted : February 16, 2011
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 16, 2011
Last Update Posted Date April 22, 2019
Estimated Study Start Date  ICMJE January 2, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Number of patients having obtained 95% or greater re-epithelialization of target burn at Day 28. [ Time Frame: 28 days of treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01297400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Degree of scarring at Day 28 and Day 56. [ Time Frame: 28 days of treatment period plus 28 days of post treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns
Official Title  ICMJE 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
Brief Summary The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with partial thickness burns.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns (Partial Thickness)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MEBO Wound Ointment (MEBO)
    Intervention: Drug: MEBO Wound Ointment (MEBO)
  • Active Comparator: Standard of care
    Intervention: Procedure: Standard practice for partial thickness burns
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2011)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vicki Christodoulou, MS, JD 909-587-1650 ext 1682 vickic@skingenixusa.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01297400
Other Study ID Numbers  ICMJE MEBO-BPII-001 v1.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Skingenix, Inc.
Study Sponsor  ICMJE Skingenix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Skingenix, Inc.
Verification Date April 2019

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