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Monolaurin Ointment Versus Mupirocin Ointment

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Early Phase 1
Locations
Philippines
Study Type
Interventional
Intervention
Monolaurin
Mupirocin ointment
Sponsored by
Victoriano Luna Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • V. Luna Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monolaurin Ointment

Mupirocin Ointment

Arm Description

treatment arm

control drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

secondary outcome measure 1
decrease in wound size in mm
secondary outcome measure 2
post-treatment gram stain and culture result

Full Information

First Posted
September 12, 2023
Last Updated
October 15, 2023
Sponsor
Victoriano Luna Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06046937
Brief Title
Monolaurin Ointment Versus Mupirocin Ointment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Victoriano Luna Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monolaurin Ointment
Arm Type
Experimental
Arm Description
treatment arm
Arm Title
Mupirocin Ointment
Arm Type
Active Comparator
Arm Description
control drug
Intervention Type
Drug
Intervention Name(s)
Monolaurin
Other Intervention Name(s)
Treatment Group
Intervention Description
applied thinly twice a day
Intervention Type
Drug
Intervention Name(s)
Mupirocin ointment
Other Intervention Name(s)
Control
Intervention Description
applied thinly twice a day
Primary Outcome Measure Information:
Title
success or failure of therapy
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
secondary outcome measure 1
Description
decrease in wound size in mm
Time Frame
7 days
Title
secondary outcome measure 2
Description
post-treatment gram stain and culture result
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sanchez, MD
Organizational Affiliation
V. Luna Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
V. Luna Medical Center
City
Quezon City
State/Province
NCR
ZIP/Postal Code
1110
Country
Philippines

12. IPD Sharing Statement

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Monolaurin Ointment Versus Mupirocin Ointment

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