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

Study Overview
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Brief Summary
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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.

Conditions
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Impetigo

Intervention / Treatment
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* Drug: papaya 1% extract ointment
* Drug: mupirocin 2% ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: papaya 1% extract ointment<br>papaya 1% extract ointment twice a day for 1 week | Drug: papaya 1% extract ointment<br> <br> |
| Active Comparator: mupirocin 2% ointment<br>mupirocin 2% ointment twice a day for 1 week | Drug: mupirocin 2% ointment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical clearance after 1 week of treatment |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to clinical clearance |  | 1 week | 
| score in the 6-point grading system | 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 | 1 week | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impetigo, papaya extract ointment