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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

Information source: Philippine Dermatological Society
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impetigo

Intervention: papaya 1% extract ointment (Drug); mupirocin 2% ointment (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Philippine Dermatological Society

Official(s) and/or principal investigator(s):
Mia Angela C Verzosa, MD, Study Director, Affiliation: St. Luke's Medical Center
Pearl Weena Marie E Sabido, MD, Principal Investigator, Affiliation: St. Luke's Medical Center
Janine L. Quijano, MD, Principal Investigator, Affiliation: St. Luke's Medical Center

Overall contact:
Janine L. Quijano, MD, Email: janinequijanoMD@gmail.com


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.

Clinical Details

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

Primary outcome: Clinical clearance after 1 week of treatment

Secondary outcome:

time to clinical clearance

score in the 6-point grading system

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


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


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


- Concurrent immunosuppressive therapy

- Patients ≤ 1 year

- Pregnant & lactating patients

Locations and Contacts

Janine L. Quijano, MD, Email: janinequijanoMD@gmail.com

St. Luke's Medical Center, Quezon City, NCR, Philippines; Recruiting
Quijano, Email: janinequijanoMD@gmail.com
Additional Information

Related publications:

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.

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.

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.

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.

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.

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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.

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.

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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.

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.

Starting date: August 2013
Last updated: December 18, 2013

Page last updated: August 23, 2015

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