NCT05219747|UnknownDMC
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Sponsor study identifier
interventional
72
1 country
1
Study Start
February 28, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Several natural products have been use to promote wound healing and relieve pain. Acmella oleracea has a component that has anesthetic and anti-inflammatory properties. The mucoadhesive film can be improved by drug delivery system due to close contact with the absorption tissue leading to improvement in both local and systemic effects. This study aims to evaluate the effectiveness and safety of mucoadhesive film containing Acmella oleracea extract in healthy subjects. This is a randomised, double-blind (participant and investigator), parallel-controlled clinical trial. In total, approximately 72 subjects will be enrolled into study. Objectives
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2021
Actual (reported)February 2, 2022
Actual (reported)February 28, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by skin prick test
Outcome will be a number of participants with skin allergic reaction assessed by skin prick test
Evaluate at 15 minutes after test in the 1st visit
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 2nd day after test
Outcome will be a number of participants with skin allergic reaction assessed by patch skin test at 2nd day after test
Evaluate at 2 days after patch skin test application
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 4th day after test
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 4th day after test.
Evaluate at 4th day after patch skin test application
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 7th day after test
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 7th day after test.
Evaluate at 7th day after patch skin test application
Mucoadhesive film containing Acmella oleracea extract
Mucoadhesive film without Acmella oleracea extract
Participants will apply a mucoadhesive film containing Acmella oleracea extract on labial mucosa of lower lip by themselves at least for 2 hours
Participants will apply a mucoadhesive film on labial mucosa of lower lip by themselves at least for 2 hours
Faculty of Dentistry , Khon Kaen University
Khon Kaen, 40002, Thailand
Kemporn Kitsahawong, DDS,MSc,PhD
Faculty of Dentistry, Khon Kaen University
First Submitted
December 1, 2021
First Posted
February 2, 2022
Study Start
February 28, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To study the duration of mucosal adhesion of mucoadhesive film in healthy oral mucosa
Outcomes will be the duration in minutes of the mucoadhesive film adhering to participant' s oral mucosa
Self reporting the time at which the film detaches (e.g. 16.30 hr.), within 24 hours after mucoadhesive film application
To study the local anesthetic effect
Outcome will be a score of Numeric rating scale (NRS) of local anesthetic effect. On a scale of 0-10, where 0 = no anesthetic effect and 10 = completely anesthetize
Self reporting at 1st visit, at 3 and 5minutes after application
To study adverse effect related to mucoadhesive film use
Outcome will be a number of participants who have adverse effect and the symptom of adverse effect
Evaluate within 2 hours after mucoadhesive film application
To evaluate participant's satisfaction
Outcome will be a score of Numeric rating scale (NRS) of satisfaction of mucoadhesive film use. On a scale of 0-10, where 0 = totally unsatisfied and 10 = the most satisfied
Evaluate at 2 hours after mucoadhesive film application
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Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 2, 2022
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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