Monolaurin Ointment Versus Mupirocin Ointment

NCT06046937 | Completed Early Phase 1 DMC

• 1 other identifier: 033/06-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• secondary outcome measure 1

  7 days

• secondary outcome measure 2

  7 days

Study Arms (2)

Monolaurin Ointment

EXPERIMENTAL

treatment arm

Drug: Monolaurin

Mupirocin Ointment

ACTIVE COMPARATOR

control drug

Drug: Mupirocin ointment

Interventions

Monolaurin DRUG

applied thinly twice a day

Also known as: Treatment Group

Monolaurin Ointment

Mupirocin ointment DRUG

applied thinly twice a day

Also known as: Control

Mupirocin Ointment

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victoriano Luna Medical Center: lead

Study Sites (1)

V. Luna Medical Center

Quezon City, NCR, 1110, Philippines

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

monolaurin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Elizabeth Sanchez, MD

  V. Luna Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Consultant

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

PH (1)