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

NCT ID: NCT01943136

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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Conditions

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Impetigo

Keywords

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impetigo papaya extract ointment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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papaya 1% extract ointment

papaya 1% extract ointment twice a day for 1 week

Group Type EXPERIMENTAL

papaya 1% extract ointment

Intervention Type DRUG

mupirocin 2% ointment

mupirocin 2% ointment twice a day for 1 week

Group Type ACTIVE_COMPARATOR

mupirocin 2% ointment

Intervention Type DRUG

Interventions

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papaya 1% extract ointment

Intervention Type DRUG

mupirocin 2% ointment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Medical Center

OTHER

Sponsor Role collaborator

Philippine Dermatological Society

NETWORK

Sponsor Role lead

Responsible Party

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Pearl Weena Marie Sabido

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mia Angela C Verzosa, MD

Role: STUDY_DIRECTOR

St. Luke's Medical Center

Pearl Weena Marie E Sabido, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Medical Center

Janine L. Quijano, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Medical Center

Locations

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St. Luke's Medical Center

Quezon City, NCR, Philippines

Site Status RECRUITING

Countries

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Philippines

Central Contacts

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Janine L. Quijano, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Quijano

Role: primary

References

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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(1):CD003261. doi: 10.1002/14651858.CD003261.pub3.

Reference Type BACKGROUND
PMID: 22258953 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19766888 (View on PubMed)

Witte W, Cuny C, Klare I, Nubel 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.

Reference Type BACKGROUND
PMID: 18325835 (View on PubMed)

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.

Reference Type BACKGROUND

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. doi: 10.1093/jac/dkg087.

Reference Type BACKGROUND
PMID: 12562687 (View on PubMed)

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.

Reference Type BACKGROUND

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. doi: 10.1067/mjw.2003.131.

Reference Type BACKGROUND
PMID: 12851592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10786448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18759075 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15040064 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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).

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Iliev D, Elsner P. Generalized drug reaction due to papaya juice in throat lozenges. Dermatology. 1997;194(4):364-6. doi: 10.1159/000246142.

Reference Type BACKGROUND
PMID: 9252760 (View on PubMed)

Niinimaki A, Reijula K, Pirila T, Koistinen AM. Papain-induced allergic rhinoconjunctivitis in a cosmetologist. J Allergy Clin Immunol. 1993 Sep;92(3):492-3. doi: 10.1016/0091-6749(93)90129-4. No abstract available.

Reference Type BACKGROUND
PMID: 8360400 (View on PubMed)

Other Identifiers

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Papaya for impetigo

Identifier Type: -

Identifier Source: org_study_id