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

NCT05219747 | Unknown DMC

• 1 other identifier: KKUHE641398
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Mucosa

Keywords

Mucoadhesive

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Study Arms (2)

A.Oleracea group

EXPERIMENTAL

Mucoadhesive film containing Acmella oleracea extract

Other: Mucoadhesive film containing Acmella oleracea extract

Placebo group

PLACEBO COMPARATOR

Mucoadhesive film without Acmella oleracea extract

Other: Mucoadhesive film without Acmella oleracea extract

Interventions

Mucoadhesive film containing Acmella oleracea extract OTHER

Participants will apply a mucoadhesive film containing Acmella oleracea extract on labial mucosa of lower lip by themselves at least for 2 hours

A.Oleracea group

Mucoadhesive film without Acmella oleracea extract OTHER

Participants will apply a mucoadhesive film on labial mucosa of lower lip by themselves at least for 2 hours

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• The participants who need dental treatment or necessary to use topical medication to treat oral diseases during the study period (7 days).
• History of allergic to the components of mucoadhesive film and/or have a history of other allergies.
• The vulnerable participants include pregnancy or lactating women and disabilities.
• 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.
• History of using topical gluco-corticosteroids during the one-week period on skin testing areas.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Dentistry , Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Study Officials

• Kemporn Kitsahawong, DDS,MSc,PhD

  Faculty of Dentistry, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemporn Kitsahawong, DDS,MSc,PhD

CONTACT

0910566996; kkempo@kku.ac.th

Patimaporn Pungchanchaikul, DDS,PhD

CONTACT

0818299182; patpun@kku.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: Randomize control trial

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 2, 2022
• Study Start: February 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)