UlcersPhase 2NCT01138436
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
A Phase 2 study testing MEBO Wound Ointment (MEBO) in people with Ulcers, run by Skingenix, Inc. at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcers
- What is being tested?
- MEBO Wound Ointment (MEBO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age.
- Able and willing to provide informed consent.
- Able and willing to comply with protocol visits and procedures.
- A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.
Who cannot join
- Ulcer of a non-venous hypertensive pathophysiology.
- Known or suspected allergy to any of the components of MEBO.
- Malignancy on target ulcer limb.
- Received another investigational device or drug within 30 days of enrollment.
- Non-compliance in the screening or run-in period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Clinical Research, Inc.
Castro Valley, California, 94546
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
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
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).
Read the 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).
- Conditions
- Ulcers
- Being tested
- MEBO Wound Ointment (MEBO), Standard of Care
- Keywords
- Venous Leg Ulcers, VLU
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEBO Wound Ointment (MEBO)Drug
Also called MEBO
Topical application once a day
Standard of CareProcedure or surgery
Application of Profore multilayer compression bandage system
| Study group | Role | What they receive |
|---|---|---|
| MEBO Wound Ointment (MEBO) | Experimental | Topical application once a day Receives: Drug: MEBO Wound Ointment (MEBO) |
| Standard of Care | Active comparator | Application of Profore multilayer compression bandage system Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete healing of the target ulcer within the 8-week treatment period.
Measured: 8 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skingenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Kirsner, MD, PhD, Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138436
- Sponsor's protocol ID
- MEBO-VSU-PII-001 v2.0
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2010
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138436
- Acronym / sponsor ID
- MEBO-VSU-PII-001 v2.0
- Conditions
- Ulcers
- Keywords
- Venous Leg Ulcers, VLU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Skingenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEBO Wound Ointment (MEBO) | Experimental | Drug: MEBO Wound Ointment (MEBO)Topical application once a day |
| Standard of Care | Active comparator | Procedure: Standard of CareApplication of Profore multilayer compression bandage system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age.
- Able and willing to provide informed consent.
- Able and willing to comply with protocol visits and procedures.
- A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.
Key exclusion criteria (5 listed)
- Ulcer of a non-venous hypertensive pathophysiology.
- Known or suspected allergy to any of the components of MEBO.
- Malignancy on target ulcer limb.
- Received another investigational device or drug within 30 days of enrollment.
- Non-compliance in the screening or run-in period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEBO Wound Ointment (MEBO)Also: MEBOTopical application once a day | Drug | MEBO Wound Ointment (MEBO) |
| Standard of CareApplication of Profore multilayer compression bandage system | Procedure or surgery | Standard of Care |
Primary outcome
Incidence of complete healing of the target ulcer within the 8-week treatment period.
Time frame: 8 week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kirsner, MD, PhD study chair
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEBO Wound Ointment (MEBO) in people with Ulcers, run by Skingenix, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete healing of the target ulcer within the 8-week treatment period. (time frame: 8 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.