A randomized, comparative study to assess the efficacy and safety of antimicrobial gauze pad coated with mangosteen extract versus 2% mupirocin ointment in the treatment of uncomplicated superficial bacterial skin infections in children.

Phase 2

• Conditions: Patients 12 months to 18 years of age Signs or symptoms of uncomplicated superficial bacterial skin infection, including both primary skin infection (impetigo, folliculitis, or minor soft tissue inf; children with skin infection

• Registration Number: TCTR20180828003
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study Completion: 2019-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients 12 months †18 years of age
2.Signs or symptoms of uncomplicated superficial bacterial skin infection, including both primary skin infection (impetigo, folliculitis, or minor soft tissue infection), and secondary skin infection (secondarily infected eczema, secondarily infected lacerations or sutured wounds or abrasions).
3.The superficial skin infection must be suitable for treatment with a topical antibacterial, not requiring surgical intervention
-Impetigo (bullous or nonbullous), folliculitis ≤ 10 lesions or ≤ 2% total body surface area.
-Secondarily infected lacerations or sutured wounds ≤ 10 cm long with surrounding erythema ≤ 2 cm from the edge of the lesion, or abrasions ≤ 2% total body surface area, with surrounding erythema ≤ 2 cm from the edge of the wound
4.Skin infection rating scale (SIRS) score at least 4 with at least 3/5 signs/symptom categories present.

Exclusion Criteria

1.Patients who have demonstrated a previous hypersensitivity reaction to mangosteen, mangosteen extract, or any component of mupirocin ointment
2.Patients who have demonstrated a previous hypersensitivity reaction to plasters or other dressing materials
3.Secondarily infected animal/human bites or puncture wounds; abscesses; probable polymicrobial chronic ulcerative lesions unlikely to have been caused by S. aureus
4.Systemic signs and symptoms of infection requiring systemic therapy (e.g. fever, with oral temperature ≥ 38.3°C, widespread lesions > 2% total body surface area) or surgical intervention; a bacterial skin infection that, in the investigator’s opinion, could not be treated appropriately by a topical antibiotic (e.g. cellulitis, furunculosis, or abscess)
5.Underlying diseases that affect immunocompetency
6.Underlying life-threatening diseases
7.The use of topical therapeutic agents on the infected lesion, and systemic antibacterial or steroids, was prohibited within 48 hours prior to study entry and during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the efficacy of antimicrobial gauze pad coated with mangosteen extract 14 days Clinical response and bacteriological response at the end of therapy

Secondary Outcome Measures

Name	Time	Method
The local safety and tolerability of antimicrobial gauze pad coated with mangosteen 14 days record side effect