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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01943136
Recruitment Status : Unknown
Verified December 2013 by Pearl Weena Marie Sabido, Philippine Dermatological Society.
Recruitment status was:  Recruiting
First Posted : September 16, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
St. Luke's Medical Center
Information provided by (Responsible Party):
Pearl Weena Marie Sabido, Philippine Dermatological Society

Study Description
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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.

Condition or disease Intervention/treatment Phase
Impetigo Drug: papaya 1% extract ointment Drug: mupirocin 2% ointment Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2013
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical clearance after 1 week of treatment [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. time to clinical clearance [ Time Frame: 1 week ]
  2. score in the 6-point grading system [ Time Frame: 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

  3. change in size of lesion compared to baseline [ Time Frame: 1 week ]
  4. presence or absence of recurrence on any part of the body 2 weeks after starting treatment [ Time Frame: 1 week ]
  5. presence or absence of adverse events during treatment [ Time Frame: 1 week ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943136


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

Locations
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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
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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
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Publications:
Craft N, Lee PK, Zipoli MT, Weinberg AN, Swartz MN, Johnson RA. "Superficial cutaneous infections and pyodermas." Ftizpatrick's Dermatology in General Medicine, 7th ed. Ed. Wolff K, et al. USA: McGraw-Hill Companies, 2008. 1694-1709.
Pineda-Rebong AM, Tan JGB. Comparison of 2% oxytetracycline ointment with 2% mupirocin ointment and 2% sodium fusidate ointment in the treatment of impetigo in children: a preliminary report. J Phil Dermatol Soc 2011 May;20(1):21-4.
Anibijuwon II, Udeze AO. Antimicrobial activity of Carica papaya (pawpaw) leaf on some pathogenic organisms of clinical origin from south-western Nigeria. Ethnobotanical Leaflets 2009;13:850-64.
Mahmood AA, Sihdik K, Salmah I. Wound healing activity of Carica papaya L. aqueous leaf extracts in rats. International Journal of Molecular Medicine and Advance Sciences 2005;1(4):398-401.
Buensalido JS, Dimagiba TE. The efficacy and safety of 1.5% carica papaya latex cream compared to 2% ketoconazole cream and vehicle in the treatment of tinea corporis: A randomized, double blind, controlled trial. J Phil Dermatol Soc 2011 May;20(1):15-20.
Canoy-Valencia H, King-Joanino SVB. An in vitro study of the therapeutic effects of Carica papaya against superficial pyodermas. Makati Medical Center Proceedings 1996;10:21-3.
Ablang AMJ, Nuguid AS. In vitro activity of Carica papaya powdered extract alone and in combination with penicillin against clinical isolates of Streptococcus pyogenes. Makati Medical Center Proceedings 2000;14:11-5.
Doughari JH, Elmahmood AM, Manzara S. Studies on the antibacterial activity of root extracts of Carica papaya L. African Journal of Microbiology Research 2007 August:37-41.
Okechukwu RI, Obasi KO, Nnoli MC, Ukaoma AA. Antimicrobial properties and preliminary phytochemical analysis of Carica papaya leaf. Advances in Science and Technology 2010;4(1):45-8.
Suresh K, Deepa P, Harisaranraj R, Achudhan V. Antimicrobial and phytochemical investication of the Carica papaya L., Cynodon dactylon (L.) Pers., Euphorbia herta L. Melia azedarach L., and Psidium guajava L. Ethnobotanical Leaflets 2008;12:1184-91.
Celis MA, Verallo-Rowell VM. Carica papaya versus Fucidin cream in the treatment of superficial pyodermas in pediatric patients: A double blind study. (Unpublished, 1996).
Oduola T, Adeniyi FAA, Ogunyemi EO, Bello IS, Idowu TO, Subair HG. Toxicity studies on an unripe Carica papaya aqueous extract: biochemical and haematological effects in wistar albino rats. Journal of Medicinal Plants Research 2007 August;1(1):1-4.

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Responsible Party: Pearl Weena Marie Sabido, Dr., Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT01943136    
Other Study ID Numbers: Papaya for impetigo
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Pearl Weena Marie Sabido, Philippine Dermatological Society:
impetigo
papaya extract ointment
Additional relevant MeSH terms:
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Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Streptococcal Infections
Skin Diseases, Bacterial
 Skin Diseases, Infectious
Skin Diseases
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action