Treatment effectiveness of triamcinolone oral paste and amlexanox oral paste in oral lichen planus
| ISRCTN | ISRCTN10134012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10134012 |
| Secondary identifying numbers | IREB/2021/OMR/09 |
- Submission date
- 11/04/2023
- Registration date
- 25/04/2023
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Oral lichen planus is an inflammatory condition that affects the mucous membranes inside the mouth. There is no specific curative drug or treatment for oral lichen planus and in most cases management relies on corticosteroids for the relief of symptoms. There is research ongoing to find alternative topical therapeutics to corticosteroids. This study aims to compare the effectiveness of topical Amlexanox 5% oral paste and triamcinolone acetonide 0.1% paste in the treatment of oral lichen planus.
Who can participate?
Patients aged 18 to 70 years with oral lichen planus
What does the study involve?
Participants are randomly allocated to be treated with either topical amlexanox paste or triamcinolone acetonide paste. The treatment continues for 1 month with three times daily drug application.
What are the possible benefits and risks of participating?
Both the corticosteroid drug and amlexanox when used in early or mild stages of oral lichen planus can arrest disease progression to severe forms and avoid the use of systemic corticosteroids and immunomodulators. The selected topical drugs have a high safety profile, favourable patient compliance and no systemic side effects.
Where is the study run from?
D Y Patil University, School of Dentistry (India)
When is the study starting and how long is it expected to run for?
November 2021 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Biswadip Shyam, biswadipshyam@gmail.com
Contact information
Principal Investigator
D Y PATIL University School of Dentistry, Dr. D Y Patil Vidyanagar
Nerul east sector 7
Navi Mumbai
400706
India
 ORCID ID |
0000-0002-1838-6277 |
|---|---|
| Phone | +91 (0)9435573849 |
| biswadipshyam@gmail.com |
Study information
| Study design | Interventional double-blind parallel-group randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparative efficacy of topical amlexanox 5% oral paste and triamcinolone acetonide 0.1% oromucosal paste in the treatment of oral lichen planus – a randomized control trial |
| Study hypothesis | Amlexanox oral paste has been compared with triamcinolone acetonide 0.1% oromucosal paste (conisidered as the gold standard therapy) in the treatment of oral lichen planus. |
| Ethics approval(s) | Approved 26/11/2021, Institutional Research & Ethical Board (D Y Patil University School of Dentistry, Navi Mumbai, Maharashtra, India; +91 (0)9029999633; dentistry@dypatul.edu), ref: IREB/2021/OMR/09 |
| Condition | Oral lichen planus |
| Intervention | 30 patients with oral lichen planus were included in the study. After clinical diagnosis and histopathological confirmation, the selected patients were divided into two groups – group A and group B, through a randomization process (chit method [lottery] followed by dispatch in opaque envelopes [allocation concealment]). Patients in group A received 0.1% triamcinolone acetonide oro-mucosal paste (n = 15) and patients in group B received 5% amlexanox oral paste (n = 15) after allocation concealment, for 1 month and their responses to the treatment were recorded. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Triamcinolone acetonide 0.1%, amlexanox 5% |
| Primary outcome measure | Size of the lesion measured using self-modified Thongprasom sign scoring system for oral lichen planus, at baseline (day 0) and days 15, 30 and 45 |
| Secondary outcome measures | 1. Pain intensity measured using the visual analogue score (VAS) at baseline (day 0) and days 15, 30 and 45 2. Clinical erythema measured using Clinician Erythema Assessment grading scale at baseline (day 0) and days 15, 30 and 45 2. Incidence of adverse drug reactions (if reported) during the treatment course 3. Quality of life assessed using the Chronic Oral Mucosal disease questionnaire (COMDQ) after treatment completion |
| Overall study start date | 20/11/2021 |
| Overall study end date | 28/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Participant inclusion criteria | 1. Patients diagnosed with oral lichen planus 2. Age range 18 to 70 years |
| Participant exclusion criteria | 1. Patients with a history of malignancy, immunocompromised diseases, metabolic diseases, pregnancy or breastfeeding, systemic viral infections, other red and white lesions 2. Undergoing systemic therapy that may interfere with disease prognosis 3. Active therapy for oral lichen planus 4. Known allergies to the study drugs |
| Recruitment start date | 10/01/2022 |
| Recruitment end date | 28/12/2022 |
Locations
Countries of recruitment
- India
Study participating centre
Nerul east, sector 7
Navi Mumbai
400706
India
Sponsor information
University/education
D Y PATIL University School of Dentistry, Dr. D Y Patil Vidyanagar
Nerul east sector 7
Navi Mumbai
400706
India
| Phone | +91 (0)8108069665 |
|---|---|
| mandavi.waghmare@dypatil.edu | |
| Website | http://www.dypatil.edu/ |
"ROR" |
https://ror.org/045qb5273 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Biswadip Shyam (biswadishyam@gmail.com). |
Editorial Notes
05/12/2023: The intention to publish date was changed from 20/06/2023 to 20/06/2024.
17/04/2023: Trial's existence confirmed by the Institutional Research & Ethical Board, D Y Patil University School of Dentistry.
