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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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.

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

ClinicalTrials.gov processed this record on July 01, 2015