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

Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138436
• Other study ID #: MEBO-VSU-PII-001 v2.0
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2019
• Source: Skingenix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Ulcers
• Varicose Ulcer

Intervention

Drug:
• MEBO Wound Ointment (MEBO)
Topical application once a day

Procedure:
• Standard of Care
Application of Profore multilayer compression bandage system

Locations

Country	Name	City	State
United States	Center for Clinical Research, Inc.	Castro Valley	California
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Skingenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete healing of the target ulcer within the 8-week treatment period.		8 week treatment period