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

This study is currently recruiting participants.
Verified December 2013 by Philippine Dermatological Society
Sponsor:
Collaborator:
St. Luke's Medical Center
Information provided by (Responsible Party):
Pearl Weena Marie Sabido, Philippine Dermatological Society
ClinicalTrials.gov Identifier:
NCT01943136
First received: August 30, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Impetigo
Drug: papaya 1% extract ointment
Drug: mupirocin 2% ointment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Philippine Dermatological Society:

Primary Outcome Measures:
  • Clinical clearance after 1 week of treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to clinical clearance [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • score in the 6-point grading system [ Time Frame: 1 week ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • presence or absence of recurrence on any part of the body 2 weeks after starting treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • presence or absence of adverse events during treatment [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: August 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: papaya 1% extract ointment
papaya 1% extract ointment twice a day for 1 week
Drug: papaya 1% extract ointment
Active Comparator: mupirocin 2% ointment
mupirocin 2% ointment twice a day for 1 week
Drug: mupirocin 2% ointment

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943136

Contacts
Contact: Janine L. Quijano, MD janinequijanoMD@gmail.com

Locations
Philippines
St. Luke's Medical Center Recruiting
Quezon City, NCR, Philippines
Contact: Quijano       janinequijanoMD@gmail.com   
Sponsors and Collaborators
Philippine Dermatological Society
St. Luke's Medical Center
Investigators
Study Director: Mia Angela C Verzosa, MD St. Luke's Medical Center
Principal Investigator: Pearl Weena Marie E Sabido, MD St. Luke's Medical Center
Principal Investigator: Janine L. Quijano, MD St. Luke's Medical Center
  More Information

Publications:

Responsible Party: Pearl Weena Marie Sabido, Dr., Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT01943136     History of Changes
Other Study ID Numbers: Papaya for impetigo
Study First Received: August 30, 2013
Last Updated: December 18, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Philippine Dermatological Society:
impetigo
papaya extract ointment

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases
Mupirocin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014