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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

Primary Purpose

Impetigo

Status
Unknown status
Phase
Phase 1
Locations
Philippines
Study Type
Interventional
Intervention
papaya 1% extract ointment
mupirocin 2% ointment
Sponsored by
Philippine Dermatological Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impetigo focused on measuring impetigo, papaya extract ointment

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • St. Luke's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

papaya 1% extract ointment

mupirocin 2% ointment

Arm Description

papaya 1% extract ointment twice a day for 1 week

mupirocin 2% ointment twice a day for 1 week

Outcomes

Primary Outcome Measures

Clinical clearance after 1 week of treatment

Secondary Outcome Measures

time to clinical clearance
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
change in size of lesion compared to baseline
presence or absence of recurrence on any part of the body 2 weeks after starting treatment
presence or absence of adverse events during treatment

Full Information

First Posted
August 30, 2013
Last Updated
December 18, 2013
Sponsor
Philippine Dermatological Society
Collaborators
St. Luke's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01943136
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philippine Dermatological Society
Collaborators
St. Luke's Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo
Keywords
impetigo, papaya extract ointment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
papaya 1% extract ointment
Arm Type
Experimental
Arm Description
papaya 1% extract ointment twice a day for 1 week
Arm Title
mupirocin 2% ointment
Arm Type
Active Comparator
Arm Description
mupirocin 2% ointment twice a day for 1 week
Intervention Type
Drug
Intervention Name(s)
papaya 1% extract ointment
Intervention Type
Drug
Intervention Name(s)
mupirocin 2% ointment
Primary Outcome Measure Information:
Title
Clinical clearance after 1 week of treatment
Time Frame
1 week
Secondary Outcome Measure Information:
Title
time to clinical clearance
Time Frame
1 week
Title
score in the 6-point grading system
Description
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
Time Frame
1 week
Title
change in size of lesion compared to baseline
Time Frame
1 week
Title
presence or absence of recurrence on any part of the body 2 weeks after starting treatment
Time Frame
1 week
Title
presence or absence of adverse events during treatment
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine L. Quijano, MD
Email
janinequijanoMD@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Angela C Verzosa, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pearl Weena Marie E Sabido, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janine L. Quijano, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Medical Center
City
Quezon City
State/Province
NCR
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quijano
Email
janinequijanoMD@gmail.com

12. IPD Sharing Statement

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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

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