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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
  Purpose

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).


Condition Intervention Phase
Ulcers
Drug: MEBO Wound Ointment (MEBO)
Procedure: Standard of Care
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, 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

Resource links provided by NLM:


Further study details as provided by Skingenix, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEBO Wound Ointment (MEBO)
Topical application once a day
Drug: MEBO Wound Ointment (MEBO)
Topical application once a day
Active Comparator: Standard of Care
Application of Profore multilayer compression bandage system
Procedure: Standard of Care
Application of Profore multilayer compression bandage system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138436

Locations
United States, California
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
Skingenix, Inc.
Investigators
Study Chair: Robert Kirsner, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: Skingenix, Inc.
ClinicalTrials.gov Identifier: NCT01138436     History of Changes
Other Study ID Numbers: MEBO-VSU-PII-001 v2.0
Study First Received: June 4, 2010
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Skingenix, Inc.:
Venous Leg Ulcers, VLU

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014