A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns
Information source: Skingenix, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns (Partial Thickness)
Intervention: MEBO Wound Ointment (MEBO) (Drug); Standard practice for partial thickness burns (Procedure)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Skingenix, Inc. Overall contact:
Vicki Christodoulou, M.S., J.D., Phone: 909-587-1650, Ext: 1682, Email: vickic@skingenixusa.com
Summary
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment
of subjects with partial thickness burns.
Clinical Details
Official title: A Phase II, Randomized, Controlled, Single-Center Pilot Study of the Efficacy and Safety of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Partial Thickness Burns
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of patients having obtained 95% or greater re-epithelialization of target burn at Day 28.
Secondary outcome: Degree of scarring at Day 28 and Day 56.
Detailed description:
MEBO-BPII-001 is a single-center, randomized, standard care-controlled pilot study of
topically applied MEBO in subjects with partial thickness burns expected to heal in 14 days.
Twice daily application of MEBO versus standard of care will be evaluated in a parallel
design. Fourteen subjects will be randomized (7 subjects per treatment arm) to one of two
treatment groups.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female between 18 and 65 years of age.
2. Capable of giving informed consent.
3. Thermal origin burns.
4. Patients must be willing to comply with treatment application.
5. Capable of understanding and complying with study protocol requirements.
6. Study target burn area has had no previous surgical excision.
Exclusion Criteria:
1. Chemical or electrical burns.
2. Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
3. Pregnant or breast-feeding female.
4. Known or suspected allergies to any of the components of MEBO.
5. Suspicion or presence of active systemic or local cancer or tumor of any kind.
6. Any immune deficiency disorder.
7. Suspected alcohol or drug abuse.
8. Participation in another investigational drug study within 30 days prior to
treatment start.
Locations and Contacts
Vicki Christodoulou, M.S., J.D., Phone: 909-587-1650, Ext: 1682, Email: vickic@skingenixusa.com Additional Information
Starting date: January 2016
Last updated: May 18, 2015
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