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

Phase 2

Completed

• Conditions: Ulcers
• Interventions: Drug: MEBO Wound Ointment (MEBO); Procedure: Standard of Care

• Registration Number: NCT01138436
• Lead Sponsor: Skingenix, Inc.

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Study Start: 2010-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2013-07-19
• Disposition First Submitted QC: 2013-07-19
• Disposition First Posted: 2013-07-23
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEBO Wound Ointment (MEBO)	MEBO Wound Ointment (MEBO)	Topical application once a day
Standard of Care	Standard of Care	Application of Profore multilayer compression bandage system

Primary Outcome Measures

Name	Time	Method
Incidence of complete healing of the target ulcer within the 8-week treatment period.	8 week treatment period

Trial Locations

Locations (2)

Center for Clinical Research, Inc.; 🇺🇸 Castro Valley, California, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States