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: Recurrent oral aphthae,

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

Brief Summary

This is A Prospective, Randomized, Open-label, Comparative,Multi-Centric, Phase III Clinical Study. The purpose of the study is toEvaluate the Efficacy and Safety of Triamcinolone Acetonide 0.1% w/w andLignocaine Hydrochloride 2.0% w/w Oromucosal Gel with Dologel-CT® in Treatmentof Recurrent Aphthous Stomatitis. The objective is to evaluate healing of ulcerfrom baseline to Day 4 between the test and reference product. The study is notyet published.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Study Completion: 2021-04-16
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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).
• 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 (Crohn’s disease, ulcerative colitis), gluten-sensitive enteropathy, dermatoses, drug eruptions, Behcet’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)	Baseline to Day 4

Secondary Outcome Measures

Name	Time	Method
To evaluate erythema and burning sensation scores from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Baseline to Day 4,6 & 8
To evaluate percentage of responders to the treatment from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Baseline to Day 4, 6 & 8
To evaluate healing of ulcers from baseline (prior to gel application on Day 1) to Days 6 and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Baseline to Day 6
To evaluate pain intensity from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Baseline to Day 4,6 & 8
To evaluate number of days of ulcer healing within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Baseline to Day 8
To evaluate improvement in patient daily activities on Days 4, 6, and 8 as compared to baseline (prior to gel application on Day 1) within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT	Day 4, 6 & 8

Trial Locations

Locations (10)

Dr.Vasantrao Pawar.Medical College, Hospital and Research Center; 🇮🇳 Nashik, MAHARASHTRA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

King George Medical university; 🇮🇳 Lucknow, UTTAR PRADESH, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Tilak Municipal Medical college & General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

M S Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Peerless Hospitex Hospital & Research Centre Ltd; 🇮🇳 Kolkata, WEST BENGAL, India

Sir Gangaram Hospital; 🇮🇳 Central, DELHI, India

Dr.Vasantrao Pawar.Medical College, Hospital and  Research Center

🇮🇳Nashik, MAHARASHTRA, India

Dr Manisha Marathe

Principal investigator

7875002421

archiespagar@gmail.com