Bacterial InfectionsEarly Phase 1NCT06046937
Monolaurin Ointment Versus Mupirocin Ointment
A Early Phase 1 study testing Monolaurin and Mupirocin ointment in people with Bacterial Infections, run by Victoriano Luna Medical Center at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Monolaurin and Mupirocin ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jun 2023to 15 Jul 2023
- Phase
- Early Phase 1
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Monolaurin, Mupirocin ointment
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonolaurinDrug
Also called Treatment Group
applied thinly twice a day
Mupirocin ointmentDrug
Also called Control
applied thinly twice a day
| Study group | Role | What they receive |
|---|---|---|
| Monolaurin Ointment | Experimental | treatment arm Receives: Drug: Monolaurin |
| Mupirocin Ointment | Active comparator | control drug Receives: Drug: Mupirocin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (2)
secondary outcome measure 1
decrease in wound size in mm
Measured: 7 days
secondary outcome measure 2
post-treatment gram stain and culture result
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoriano Luna Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wenzyl Jean Etor, Victoriano Luna Medical Center
- Investigators
- Elizabeth Sanchez, MD, Study chair, V. Luna Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046937
- Sponsor's protocol ID
- 033/06-20
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06046937
- Acronym / sponsor ID
- 033/06-20
- Conditions
- Bacterial Infections
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Victoriano Luna Medical CenterOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monolaurin Ointment | Experimental | Drug: Monolaurintreatment arm |
| Mupirocin Ointment | Active comparator | Drug: Mupirocin ointmentcontrol drug |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| MonolaurinAlso: Treatment Groupapplied thinly twice a day | Drug | Monolaurin Ointment |
| Mupirocin ointmentAlso: Controlapplied thinly twice a day | Drug | Mupirocin Ointment |
Primary outcome
success or failure of therapy
Time frame: 7 days
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
2 secondary outcomes
secondary outcome measure 1
Time frame: 7 days
secondary outcome measure 2
Time frame: 7 days
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 17 Oct 2023.
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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.
Elizabeth Sanchez, MD study chair
V. Luna Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Monolaurin and Mupirocin ointment in people with Bacterial Infections, run by Victoriano Luna Medical Center at 1 site in Philippines.
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 6 inclusion and 12 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
success or failure of therapy (time frame: 7 days). 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 17 Oct 2023.