Clinical trial NCT05219747: The Effectiveness and Safety of Mucoadhesive Film Containing A.Oleracea Extract
Official title: The Effectiveness and Safety of Mucoadhesive Film Containing Acmella Oleracea Extract in Healthy Subjects: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Mucosa
Keywords: Mucoadhesive
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomize control trial
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy people age 18-60 years old and do not have regular medication.
2. Able to give the consent formation in a study and to cooperate in answering questionnaires or data records in google formation.
3. The participants must not have any wounds, tattoos, inflammation or pathology on the oral mucosa and skin of testing area.
4. The participants who can come to follow up for a specified period of time.

Exclusion Criteria:

1. The participants who need dental treatment or necessary to use topical medication to treat oral diseases during the study period (7 days).
2. History of allergic to the components of mucoadhesive film and/or have a history of other allergies.
3. The vulnerable participants include pregnancy or lactating women and disabilities.
4. History of using antihistamines drugs during the one-week period prior to joining the study or participants who need to use such antihistamines during the time participating in the study.
5. History of using topical gluco-corticosteroids during the one-week period on skin testing areas.

Primary outcomes:
measure: To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by skin prick test
timeFrame: Evaluate at 15 minutes after test in the 1st visit
measure: To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 2nd day after test
timeFrame: Evaluate at 2 days after patch skin test application
measure: To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 4th day after test
timeFrame: Evaluate at 4th day after patch skin test application
measure: To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 7th day after test
timeFrame: Evaluate at 7th day after patch skin test application
measure: To study the duration of mucosal adhesion of mucoadhesive film in healthy oral mucosa
timeFrame: Self reporting the time at which the film detaches (e.g. 16.30 hr.), within 24 hours after mucoadhesive film application
measure: To study the local anesthetic effect
timeFrame: Self reporting at 1st visit, at 3 and 5minutes after application
measure: To study adverse effect related to mucoadhesive film use
timeFrame: Evaluate within 2 hours after mucoadhesive film application
measure: To evaluate participant's satisfaction
timeFrame: Evaluate at 2 hours after mucoadhesive film application
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Dentistry , Khon Kaen University
Study officials:
affiliation: Faculty of Dentistry, Khon Kaen University
name: Kemporn Kitsahawong, DDS,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: