Trial record 14 of 171 for:    Open Studies | "Skin Diseases, Infectious"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Philippine Dermatological Society
Sponsor:
Collaborator:
St. Luke's Medical Center
Information provided by (Responsible Party):
Pearl Weena Marie Sabido, Philippine Dermatological Society
ClinicalTrials.gov Identifier:
NCT01943136
First received: August 30, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Impetigo
Drug: papaya 1% extract ointment
Drug: mupirocin 2% ointment
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Philippine Dermatological Society:

Primary Outcome Measures:
  • Clinical clearance after 1 week of treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to clinical clearance [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • score in the 6-point grading system [ Time Frame: 1 week ] [ Designated as safety issue: No ]

    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

  • change in size of lesion compared to baseline [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • presence or absence of recurrence on any part of the body 2 weeks after starting treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • presence or absence of adverse events during treatment [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: August 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943136

Contacts
Contact: Janine L. Quijano, MD janinequijanoMD@gmail.com

Locations
Philippines
St. Luke's Medical Center Recruiting
Quezon City, NCR, Philippines
Contact: Quijano       janinequijanoMD@gmail.com   
Sponsors and Collaborators
Philippine Dermatological Society
St. Luke's Medical Center
Investigators
Study Director: Mia Angela C Verzosa, MD St. Luke's Medical Center
Principal Investigator: Pearl Weena Marie E Sabido, MD St. Luke's Medical Center
Principal Investigator: Janine L. Quijano, MD St. Luke's Medical Center
  More Information

Publications:

Responsible Party: Pearl Weena Marie Sabido, Dr., Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT01943136     History of Changes
Other Study ID Numbers: Papaya for impetigo
Study First Received: August 30, 2013
Last Updated: December 18, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Philippine Dermatological Society:
impetigo
papaya extract ointment

Additional relevant MeSH terms:
Staphylococcal Skin Infections
Skin Diseases, Infectious
Impetigo
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Infection
Skin Diseases
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014