ImpetigoPhase 1NCT01943136
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
A Phase 1 study testing papaya 1% extract ointment and mupirocin 2% ointment in people with Impetigo, run by Philippine Dermatological Society at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Impetigo
- What is being tested?
- papaya 1% extract ointment and mupirocin 2% ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2013to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Janine L. Quijano, MD contact
Philippines1 site, 1 recruiting
- Recruiting
St. Luke's Medical Center
Quezon City, NCR
Quijano, janinequijanoMD@gmail.com
About this study
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.
- Conditions
- Impetigo
- Being tested
- papaya 1% extract ointment, mupirocin 2% ointment
- Keywords
- impetigo, papaya extract ointment
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papaya 1% extract ointmentDrug
mupirocin 2% ointmentDrug
| Study group | Role | What they receive |
|---|---|---|
| papaya 1% extract ointment | Experimental | papaya 1% extract ointment twice a day for 1 week Receives: Drug: papaya 1% extract ointment |
| mupirocin 2% ointment | Active comparator | mupirocin 2% ointment twice a day for 1 week Receives: Drug: mupirocin 2% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical clearance after 1 week of treatment
Measured: 1 week
Secondary outcomes (5)
time to clinical clearance
Measured: 1 week
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
Measured: 1 week
change in size of lesion compared to baseline
Measured: 1 week
presence or absence of recurrence on any part of the body 2 weeks after starting treatment
Measured: 1 week
presence or absence of adverse events during treatment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippine Dermatological Society
- Sponsor type
- Research network
- Collaborators
- St. Luke's Medical Center
- Responsible party
- Principal investigator, Pearl Weena Marie Sabido, Philippine Dermatological Society
- Investigators
- Mia Angela C Verzosa, MD, Study director, St. Luke's Medical CenterPearl Weena Marie E Sabido, MD, Principal investigator, St. Luke's Medical CenterJanine L. Quijano, MD, Principal investigator, St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943136
- Sponsor's protocol ID
- Papaya for impetigo
- Status last verified
- Dec 2013
- First submitted
- 30 Aug 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
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(1):CD003261. doi: 10.1002/14651858.CD003261.pub3.
PubMed 22258953Craft 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.
PubMed 19766888Witte 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.
PubMed 18325835Pineda-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. doi: 10.1093/jac/dkg087.
PubMed 12562687Anibijuwon 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. doi: 10.1067/mjw.2003.131.
PubMed 12851592Hewitt 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 10786448Owoyele 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 18759075Mahmood 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01943136
- Acronym / sponsor ID
- Papaya for impetigo
- Conditions
- Impetigo
- Keywords
- impetigo, papaya extract ointment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Philippine Dermatological SocietyResearch network
- Collaborators
- St. Luke's Medical Center
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (estimated)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| papaya 1% extract ointment | Experimental | Drug: papaya 1% extract ointmentpapaya 1% extract ointment twice a day for 1 week |
| mupirocin 2% ointment | Active comparator | Drug: mupirocin 2% ointmentmupirocin 2% ointment twice a day for 1 week |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| papaya 1% extract ointment | Drug | papaya 1% extract ointment |
| mupirocin 2% ointment | Drug | mupirocin 2% ointment |
Primary outcome
Clinical clearance after 1 week of treatment
Time frame: 1 week
5 secondary outcomes
time to clinical clearance
Time frame: 1 week
score in the 6-point grading system
Time frame: 1 week
change in size of lesion compared to baseline
Time frame: 1 week
presence or absence of recurrence on any part of the body 2 weeks after starting treatment
Time frame: 1 week
presence or absence of adverse events during treatment
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 22258953Koning 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.
- BackgroundCraft 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: PubMed 19766888Woodford 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.
- Background: PubMed 18325835Witte 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.
- BackgroundPineda-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: PubMed 12562687Martin 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.
- BackgroundAnibijuwon 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: PubMed 12851592Pieper 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.
- Background: PubMed 10786448Hewitt 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.
- Background: PubMed 18759075Owoyele 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.
- BackgroundMahmood 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.
- BackgroundBuensalido 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine L. Quijano, MD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing papaya 1% extract ointment and mupirocin 2% ointment in people with Impetigo, run by Philippine Dermatological Society at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janine L. Quijano, MD (janinequijanoMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical clearance after 1 week of treatment (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943136, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.