The Efficacy and Safety of Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel in Patients with Mouth Ulcers.

Phase 3

Completed

• Conditions: Health Condition 1: K120- Recurrent oral aphthae

• Registration Number: CTRI/2020/09/027952
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

A patient must fulfil all the following criteria for inclusion in this study:

1. Males and females between ages 18 and 50 years (both inclusive).

2. Females of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as intrauterine device, contraceptive pill or depot gestagen) throughout the study

3. History of recurrence ulcers in oral cavity with at least two episodes of minor and/or major RAS last year with no signs of systemic disease

4. Presence of mucosal oral ulcers, each measuring 2 mm to 3 cm in size

5. Moderate to severe pain (>= 40 mm on 100 mm VAS) on the day of baseline visit

6. Patients willing to comply with the study procedures and requirements

7. Patients willing to sign and date written informed consent to participate in the study

Exclusion Criteria

A patient will not be included in the study if they meet any of the exclusion criteria:

1. History of systemic diseases/illnesses causing oral ulceration like autoimmune conditions (systemic lupus erythematosus, Kawasaki disease), inflammatory conditions (Crohnâ??s disease, ulcerative colitis), gluten-sensitive enteropathy, dermatoses, drug eruptions, Behcetâ??s disease, Reiter syndrome, allergic conditions

2. Patients with herpetiform ulceration

3. Ulcers present at pharyngeal area

4. Patients with significant past history of cardiovascular disease (e.g. bradycardia or impaired cardiovascular function, ischemic heart disease, severe shock), impaired hepatic and renal function, sepsis, epilepsy; diabetes, uncontrolled hypertension, acid peptic disease, iron deficiency anemia, bleeding disorders, erosive gastritis, asthma, dehydration, neutropenia, folic acid or tuberculosis, association of ulcers with luteal phase of menstruation in female patients and other infections that may contraindicate treatment, as per Investigator discretion

5. Patients diagnosed with anxiety, mental or psychological disorders

6. Patients known to have hematinic deficiency or getting treatment for same

7. Patients undergoing dental treatment, with removable prosthetic rehabilitations or orthodontic appliances or having active periodontitis

8. Known history of hypersensitivity to local anesthetics of the amide type (e.g. Prilocaine, Mepivacaine) ester local anesthetics or corticosteroids or to other components in the formulation like methylparaben and/or propyl paraben or to their metabolite para aminobenzoic acid or choline salicylate

9. Patients on concomitant medications that may interact with study medication like anti-arrhythmic (e.g. Mexiletine, Amiodarone), antidepressants, sedative-hypnotics, psychotropic drugs

10. Participation in any other clinical study in past 30 days

11. Patients with other mucosal lesions with minor/major RAS and/or bacterial, yeast, viral or fungal infection at or near the proposed area of topical application

12. Ingestion of any chemotherapeutic drugs, immunomodulators or systemic corticosteroids in the recent 1 year

13. Patients whose ulcers clinically seem malignant in nature to the Investigator

14. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating

15. Patients who are unsuitable for any other reason to participate in the study in the opinion of the Investigator

16. Patients who uses topical gel other than the study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate healing of ulcer from baseline (prior to gel application on Day 1) to Day 4 between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT, when used in the treatment of recurrent aphthous stomatitis (RAS)Timepoint: Baseline to Day 4