Monolaurin Ointment Versus Mupirocin Ointment

A Randomized, Double-Blind Controlled Trial of Monolaurin Ointment Versus Mupirocin Ointment of Bacterial Skin Infections Among Pediatric Patients 5-18 Years Old in Community-Based Setting

Skin infection remains one of the leading causes of pediatric consults especially in developing countries like the Philippines. This common condition has not been considered a significant problem that could cause alarm as public health importance. Furthermore, due to the consideration that skin diseases are benign, not life-threatening, and low priority.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Monolaurin; Drug: Mupirocin ointment

Detailed Description

The advanced technology of modern science aims to formulate a new class of antibiotics due to the emergence of antibiotic resistance in microorganisms becoming a concerning threat in the medical community. Nowadays, the use of traditional medicines derived from natural plants is in increasing demand which is geared toward going back to nature as a source of medications. 17 Recently natural plants have gained popularity in society for their medical purposes, which have important therapeutic properties that can be used in the treatment of emerging and re-emerging diseases. 17,18 Pharmaceutical companies continue to do vigorous research to discover a new antimicrobial compound with a new mechanism of action for new infectious diseases and consistently tried to find solutions to the problem of multiple resistance to the existing synthetic and conventional antimicrobial agents. Therefore, more researchers and investigators direct their attention to antimicrobial of plant origin which is found to be less in adverse reactions. 5,19 Monolaurin is a type of monoacylglycerol from lauric acid. This can be produced from varieties of oil including coconut oil. Monolaurin is included on the FDA's Generally Recognized as Safe (GRAS) list and is widely used in food manufacturing. Coconut oil naturally contains around 40-50% lauric acid, the principal compound used to make monolaurin. Studies showed, both in vitro and in vivo that monolaurin and lauric acid are very active against pathogenic bacteria. They act through several mechanisms, namely (Dayrit, 2014) (1) destruction of lipid-coated bacterial and viral cell membranes by physicochemical processes, (2) disturbances of the signal transduction and transcription in cells, (3) stabilization of the host-cells membrane (human cells). 29 Furthermore, limited clinical trials were reported on the use of monolaurin against skin infection specifically in the pediatric population. The null hypothesis of this study is that the monolaurin ointment is equivalent to mupirocin ointment in efficacy. The objective of this study was to determine the clinical efficacy of monolaurin ointment versus mupirocin ointment in the treatment of skin infections, in a community-based setting.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Philippines
  • NCR
    • Quezon City, NCR, Philippines, 1110
      • V. Luna Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject aged 5 years old to 18 years old (school-aged children)
• Subjects has infected wound (laceration, sutured wound or abrasion), impetigo and other bacterial skin infections (positive gram stain or culture)
• Subject has total skin infection rating scale score of at least 4 including pus/exudate score of at least 1
• Subject parent/legal guardian is willing and able to comply with protocol (see attached consent)
• Subject parent/legal guardian has given written informed consent or assent as applicable.
• Patient has good hygiene

Exclusion Criteria:

• Previous hypersensitivity to Mupirocin
• Secondary- infected animal/human bite or punctured wound
• Subject has a large draining abscess
• Chronic ulcerative lesion
• Other underlying skin disease
• Patient is severely malnourished
• Systemic signs and symptoms of infection
• Infection not to be appropriately treated with topical antibiotic
• Infections requires surgical intervention prior to study
• Subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
• Serious underlying medical conditions/ diseases (diabetes mellitus)
• Other investigational drug within 30 days of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monolaurin Ointment; treatment arm	Drug: Monolaurin; applied thinly twice a day; Other Names: Treatment Group
Active Comparator: Mupirocin Ointment; control drug	Drug: Mupirocin ointment; applied thinly twice a day; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success or failure of therapy	clinical success is determined by sufficient resolution of signs and symptoms of infection using Skin Infection Rating Scale (SIRS) Scoring: 0=absent, 1=mild, 2=moderate, 3=severe	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcome measure 1	decrease in wound size in mm	7 days
secondary outcome measure 2	post-treatment gram stain and culture result	7 days

Collaborators and Investigators

• Sponsor: Victoriano Luna Medical Center
• Investigators: Study Chair: Elizabeth Sanchez, MD, V. Luna Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protective Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Cariostatic Agents; Mupirocin; Monolaurin
• Other Study ID Numbers: 033/06-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No