NCT01943136

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

August 30, 2013

Last Update Submit

December 18, 2013

Conditions

Impetigo

Keywords

impetigopapaya extract ointment

Outcome Measures

Primary Outcomes (1)

  • Clinical clearance after 1 week of treatment

    1 week

Secondary Outcomes (5)

  • time to clinical clearance

    1 week

  • score in the 6-point grading system

    1 week

  • change in size of lesion compared to baseline

    1 week

  • presence or absence of recurrence on any part of the body 2 weeks after starting treatment

    1 week

  • presence or absence of adverse events during treatment

    1 week

Study Arms (2)

papaya 1% extract ointment

EXPERIMENTAL

papaya 1% extract ointment twice a day for 1 week

Drug: papaya 1% extract ointment

mupirocin 2% ointment

ACTIVE COMPARATOR

mupirocin 2% ointment twice a day for 1 week

Drug: mupirocin 2% ointment

Interventions

papaya 1% extract ointmentDRUG
papaya 1% extract ointment
mupirocin 2% ointmentDRUG
mupirocin 2% ointment

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Medical Center

Quezon City, NCR, Philippines

RECRUITING

Related Publications (22)

  • 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.

    PMID: 22258953BACKGROUND

  • 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.

    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.

    PMID: 19766888BACKGROUND

  • 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.

    PMID: 18325835BACKGROUND

  • 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.

    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.

    PMID: 12562687BACKGROUND

  • 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.

    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.

    PMID: 12851592BACKGROUND

  • 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.

    PMID: 10786448BACKGROUND

  • 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.

    PMID: 18759075BACKGROUND

  • 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.

    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.

    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.

    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.

    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.

    PMID: 15040064BACKGROUND

  • 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.

    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.

    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.

    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).

    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.

    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.

    PMID: 9252760BACKGROUND

  • 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.

    PMID: 8360400BACKGROUND

MeSH Terms

Conditions

Impetigo

Interventions

MupirocinOintments

Condition Hierarchy (Ancestors)

Staphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Mia Angela C Verzosa, MD

    St. Luke's Medical Center

    STUDY DIRECTOR

  • Pearl Weena Marie E Sabido, MD

    St. Luke's Medical Center

    PRINCIPAL INVESTIGATOR

  • Janine L. Quijano, MD

    St. Luke's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janine L. Quijano, MD

CONTACT

janinequijanoMD@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 16, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations

PH(1)