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

NCT05219747 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-02-02

No results posted yet for this study

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

Conditions

  • Oral Mucosa

Interventions

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

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Kemporn Kitsahawong, DDS,MSc,PhD · Faculty of Dentistry, Khon Kaen University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05219747 on ClinicalTrials.gov