The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial

Phase 1

• Conditions: Impetigo
• Interventions: Drug: papaya 1% extract ointment; Drug: mupirocin 2% ointment

• Registration Number: NCT01943136
• Lead Sponsor: Philippine Dermatological Society

Brief Summary

This study will be an investigator-blinded, patient-blinded, assessor-blinded, parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week twice-daily application of topical papaya leaf extract ointment compared to mupirocin ointment in achieving clinical cure among patients with impetigo.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Healthy Filipino patients aged 1 year and above with primary impetigo, limited to less than or equal to 1% BSA, and involving only one body area

Exclusion Criteria

• Extensive impetigo (>1% BSA), affecting more than one body area
• Systemic involvement (lymphadenopathy, fever, sepsis)
• Chronic comorbidities like diabetes mellitus, malignancy, chronic venous insufficiency
• Concurrent immunosuppressive therapy
• Patients ≤ 1 year
• Pregnant & lactating patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
papaya 1% extract ointment	papaya 1% extract ointment	papaya 1% extract ointment twice a day for 1 week
mupirocin 2% ointment	mupirocin 2% ointment	mupirocin 2% ointment twice a day for 1 week

Primary Outcome Measures

Name	Time	Method
Clinical clearance after 1 week of treatment	1 week

Secondary Outcome Measures

Name	Time	Method
time to clinical clearance	1 week
score in the 6-point grading system	1 week	The 6-point grading system will assess clinical response based on each of the following six paramaters. One point will be assigned for each of the following parameters present in a patient, with the maximum possible score on this grading system being 6. A patient need not satisfy all six parameters. A decrease in score on this grading system compared to baseline will indicate clinical improvement, while an increase in score will indicate clinical worsening.; * erythema; * edema; * vesiculation; * pustulation; * crusting; * scaling
change in size of lesion compared to baseline	1 week
presence or absence of recurrence on any part of the body 2 weeks after starting treatment	1 week
presence or absence of adverse events during treatment	1 week

Trial Locations

Locations (1)

St. Luke's Medical Center; 🇵🇭 Quezon City, NCR, Philippines