A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Skingenix, Inc.
ClinicalTrials.gov Identifier:
NCT01138436
First received: June 4, 2010
Last updated: July 23, 2013
Last verified: July 2013

June 4, 2010
July 23, 2013
November 2010
October 2011   (final data collection date for primary outcome measure)
Incidence of complete healing of the target ulcer within the 8-week treatment period. [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01138436 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Venous Leg Ulcers

This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcers
  • Drug: MEBO Wound Ointment (MEBO)
    Topical application once a day
  • Procedure: Standard of Care
    Application of Profore multilayer compression bandage system
  • Experimental: MEBO Wound Ointment (MEBO)
    Topical application once a day
    Intervention: Drug: MEBO Wound Ointment (MEBO)
  • Active Comparator: Standard of Care
    Application of Profore multilayer compression bandage system
    Intervention: Procedure: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female ≥18 years of age.
  2. Able and willing to provide informed consent.
  3. Able and willing to comply with protocol visits and procedures.
  4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.

Exclusion Criteria:

  1. Ulcer of a non-venous hypertensive pathophysiology.
  2. Known or suspected allergy to any of the components of MEBO.
  3. Malignancy on target ulcer limb.
  4. Received another investigational device or drug within 30 days of enrollment.
  5. Non-compliance in the screening or run-in period.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01138436
MEBO-VSU-PII-001 v2.0
Not Provided
Skingenix, Inc.
Skingenix, Inc.
Not Provided
Study Chair: Robert Kirsner, MD, PhD University of Miami
Skingenix, Inc.
July 2013

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