NCT05219747

The Effectiveness and Safety of Mucoadhesive Film Containing A.Oleracea Extract

The Effectiveness and Safety of Mucoadhesive Film Containing Acmella Oleracea Extract in Healthy Subjects: A Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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 1. To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract in healthy subjects 2. To study the duration of mucosal adhesion of mucoadhesive film 3. To study the local anesthetic effect, participant's satisfaction and adverse effect of mucoadhesive film containing Acmella oleracea extract

Detailed description

Total 72 Participants will divided into 2 groups by dentist who was not an examiner performed the randomization using blocked randomization (block of 4) from program of https://www.sealedenvelope.com/simple-randomiser/v1/lists/1. Study group will receive mucoadhesive film containing Acmella oleracea extract while control group will receive mucoadhesive film without active component. All participants in the study group will be test for allergic reaction of mucoadhesive film by skin prick test and patch skin test before testing and have to follow-up appointments (at 2, 4 and 7 days after skin test). At first visit, all participants will received oral examination and informed how to use mucoadhesive film by examiner. Then participants will asked to apply the mucoadhesive film at oral mucosa of lower lip. The effectiveness of intra-oral mucoadhesive film in this study will evaluated as follows : 1. Duration of mucosal adhesion and adverse effect by self report 2. The local anesthetic effect by using Numeric rating scale (NRS) 3. Participant's satisfaction by using Numeric rating scale (NRS) The statistical methods : General and oral health data, duration of mucosal adhesion will reported as frequencies, percentages and means (Standard deviation). The different of NRS score between groups will analyzed Independent t- test or Mann-Whitney U test. Using SPSS software. Statistically significant will considered at p-value \< 0.05.

Conditions

• Oral Mucosa

Interventions

Type	Name	Description
OTHER	Mucoadhesive film containing 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
OTHER	Mucoadhesive film without Acmella oleracea extract	Participants will apply a mucoadhesive film on labial mucosa of lower lip by themselves at least for 2 hours

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: Thailand