Impetigo
Conditions
Keywords
impetigo, papaya extract ointment
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.
Interventions
DRUGpapaya 1% extract ointment
Sponsors
St. Luke's Medical Center
Philippine Dermatological Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical clearance after 1 week of treatment | 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Philippines
Contacts
Primary ContactJanine L. Quijano, MD
Outcome results
None listed