Clinical Trial: 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
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: Philippine Dermatological Society
Current Primary Outcome: Clinical clearance after 1 week of treatment [ Time Frame: 1 week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- time to clinical clearance [ Time Frame: 1 week ]
- score in the 6-point grading system [ Time Frame: 1 week ]
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 ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: Philippine Dermatological Society
Dates:
Date Received: August 30, 2013
Date Started: August 2013
Date Completion:
Last Updated: December 18, 2013
Last Verified: December 2013
