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History of Changes for Study: 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
Latest version (submitted December 18, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 11, 2013 None (earliest Version on record)
2 December 18, 2013 Recruitment Status, Contacts/Locations, Study Status and Sponsor/Collaborators
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Study NCT01943136
Submitted Date:  December 18, 2013 (v2)

Open or close this module Study Identification
Unique Protocol ID: Papaya for impetigo
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
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Unknown status [Previously: Recruiting]
Study Start: August 2013
Primary Completion: June 2015 [Anticipated]
Study Completion:
First Submitted: August 30, 2013
First Submitted that
Met QC Criteria:
September 11, 2013
First Posted: September 16, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 18, 2013
Last Update Posted: December 19, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Philippine Dermatological Society
Responsible Party: Principal Investigator
Investigator: Pearl Weena Marie Sabido
Official Title: Dr.
Affiliation: Philippine Dermatological Society
Collaborators: St. Luke's Medical Center
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Impetigo
Keywords: impetigo
papaya extract ointment
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 128 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical clearance after 1 week of treatment
1 week
Secondary Outcome Measures:
2. time to clinical clearance
1 week
3. 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


[Time Frame: 1 week]
4. change in size of lesion compared to baseline
1 week
5. presence or absence of recurrence on any part of the body 2 weeks after starting treatment
1 week
6. presence or absence of adverse events during treatment
1 week
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Mia Angela C Verzosa, MD
Study Director
St. Luke's Medical Center
Pearl Weena Marie E Sabido, MD
Principal Investigator
St. Luke's Medical Center
Janine L. Quijano, MD
Principal Investigator
St. Luke's Medical Center
Locations: Philippines, NCR
St. Luke's Medical Center
Quezon City, NCR, Philippines
Contact:Contact: Quijano janinequijanoMD@gmail.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Koning S, van der Sande R, Verhagen AP, van Suijlekom-Smit LW, Morris AD, Butler CC, Berger M, van der Wouden JC. Interventions for impetigo. Cochrane Database Syst Rev. 2012 Jan 18;1:CD003261. doi: 10.1002/14651858.CD003261.pub3. Review. PubMed 22258953
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.
Woodford N, Livermore DM. Infections caused by Gram-positive bacteria: a review of the global challenge. J Infect. 2009 Sep;59 Suppl 1:S4-16. doi: 10.1016/S0163-4453(09)60003-7. Review. PubMed 19766888
Witte W, Cuny C, Klare I, Nübel U, Strommenger B, Werner G. Emergence and spread of antibiotic-resistant Gram-positive bacterial pathogens. Int J Med Microbiol. 2008 Jul;298(5-6):365-77. doi: 10.1016/j.ijmm.2007.10.005. Epub 2008 Mar 5. Review. PubMed 18325835
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.
Martin KW, Ernst E. Herbal medicines for treatment of bacterial infections: a review of controlled clinical trials. J Antimicrob Chemother. 2003 Feb;51(2):241-6. Review. PubMed 12562687
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.
Pieper B, Caliri MH. Nontraditional wound care: A review of the evidence for the use of sugar, papaya/papain, and fatty acids. J Wound Ostomy Continence Nurs. 2003 Jul;30(4):175-83. Review. PubMed 12851592
Hewitt H, Whittle S, Lopez S, Bailey E, Weaver S. Topical use of papaya in chronic skin ulcer therapy in Jamaica. West Indian Med J. 2000 Mar;49(1):32-3. PubMed 10786448
Owoyele BV, Adebukola OM, Funmilayo AA, Soladoye AO. Anti-inflammatory activities of ethanolic extract of Carica papaya leaves. Inflammopharmacology. 2008 Aug;16(4):168-73. doi: 10.1007/s10787-008-7008-0. PubMed 18759075
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.
Dawkins G, Hewitt H, Wint Y, Obiefuna PC, Wint B. Antibacterial effects of Carica papaya fruit on common wound organisms. West Indian Med J. 2003 Dec;52(4):290-2. PubMed 15040064
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.
Iliev D, Elsner P. Generalized drug reaction due to papaya juice in throat lozenges. Dermatology. 1997;194(4):364-6. PubMed 9252760
Niinimäki A, Reijula K, Pirilä T, Koistinen AM. Papain-induced allergic rhinoconjunctivitis in a cosmetologist. J Allergy Clin Immunol. 1993 Sep;92(3):492-3. PubMed 8360400
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