Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers

Khon Kaen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Aphthous Stomatitis

Treatments: Other: mucoadhesive film without Acmella oleracea extract; Other: mucoadhesive film with Acmella oleracea extract; Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06622213

D43DE032294 (U.S. NIH Grant/Contract)

KKUHE671243

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of mucoadhesive film with or without Acmella oleracea extract compared to standard treatment by using 0.1% triamcinolone acetonide in pain relief, promoting wound healing, healing time and satisfaction in 3 aspects included taste, product used and quality of life after using the product.

Full description

Participants who consent and meet the inclusion criteria will be allocated into 3 groups using block randomization: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy participants aged 18-50 years without any underlying diseases.

2. Participants are voluntary and have signed the informed consent.

3. Participants are literate.

4. Participants can follow the treatment guidelines and follow up.

5. Participants have one untreated oral ulcer lesion.

   • An ulcer has occurred within 48 hours.
   • The ulcer size is less than 10 mm.
   • The ulcer is clearly visible and located on non-keratinized oral mucosa such as buccal mucosa, labial mucosa, alveolar mucosa, or buccal vestibule.
   • The ulcer must be painful.

6. If an ulcer is caused by a denture or orthodontic appliance, the cause must be eliminated before participation.

7. Participants must not be currently participating in any other clinical studies about oral ulcer

Exclusion criteria

1. Participants with allergies to herbal extracts, Acmella oleracea, or steroids.
2. Participants with chronic underlying diseases.
3. Participants with underlying diseases that may affect wound healing.
4. Participants receiving anti-analgesic drug, systemic steroids, antibiotics, hormones, NSAIDS, or any drugs that affect the oral mucosa.
5. Oral ulcer lesion larger than 10 mm or lesions resembling herpetic form of aphthous ulcers.
6. Oral ulcers are caused by infection or associated with systemic diseases.
7. Participants with poor oral hygiene requiring emergency treatment.
8. Participants who smoke or consume alcohol regularly.
9. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups, including a placebo group

mucoadhesive film with Acmella oleracea extract

Experimental group

Description:

Participants received mucoadhesive film with Acmella oleracea extract.

Treatment:

Other: mucoadhesive film with Acmella oleracea extract

Triamcinolone acetonide

Active Comparator group

Description:

Participants received 0.1% Triamcinolone acetonide.

Treatment:

Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste

mucoadhesive film without Acmella oleracea extract

Placebo Comparator group

Description:

Participants received mucoadhesive film without Acmella oleracea extract.

Treatment:

Other: mucoadhesive film without Acmella oleracea extract