Clinical trial NCT01943136: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Impetigo
Keywords: impetigo
papaya extract ointment
Lead sponsor: Philippine Dermatological Society
Sponsor class: NETWORK
Collaborators: name: St. Luke's Medical Center
First posted: 2013-09-16
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical clearance after 1 week of treatment
timeFrame: 1 week
Secondary outcomes:
measure: time to clinical clearance
timeFrame: 1 week
measure: score in the 6-point grading system
timeFrame: 1 week
measure: change in size of lesion compared to baseline
timeFrame: 1 week
measure: presence or absence of recurrence on any part of the body 2 weeks after starting treatment
timeFrame: 1 week
measure: presence or absence of adverse events during treatment
timeFrame: 1 week
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: NCR
Study officials:
affiliation: St. Luke's Medical Center
name: Mia Angela C Verzosa, MD
role: STUDY_DIRECTOR
affiliation: St. Luke's Medical Center
name: Pearl Weena Marie E Sabido, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Medical Center
name: Janine L. Quijano, MD
role: PRINCIPAL_INVESTIGATOR
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