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

Skingenix, Inc.5 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcers

Interventions

MEBO Wound Ointment (MEBO)DRUG

Topical application once a day

Standard of CarePROCEDURE

Application of Profore multilayer compression bandage system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Center for Clinical Research, Inc.

Castro Valley, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 8 week treatment period

Data from ClinicalTrials.gov

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