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

Philippine Dermatological Society

Status and phase: Unknown; Phase 1

Conditions: Impetigo

Treatments: Drug: mupirocin 2% ointment; Drug: papaya 1% extract ointment

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01943136

Papaya for impetigo

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

papaya 1% extract ointment

Experimental group

Description:

papaya 1% extract ointment twice a day for 1 week

Treatment:

Drug: papaya 1% extract ointment

mupirocin 2% ointment

Active Comparator group

Description:

mupirocin 2% ointment twice a day for 1 week

Treatment:

Drug: mupirocin 2% ointment