AN OPEN LABEL, MULTI-CENTER, SINGLE-ARM TREATMENT, CLINICAL TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF AN APPLICATOR WITH ACTIVE INGREDIENTS TRICHLORO ACETIC ACID 25% AND LIDOCAINE 2% IN LIQUID FORM, IN HUMAN ADULT, PATIENTS WITH RECURRENT APHTHOUS STOMATITIS (RAS). - TRIC-001-20

RAJALAKSHMI HOSPITA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Ã¢â?¬Â¢Adult, non smoking, human above 18 years
•Ã¢â?¬Â¢Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
•Ã¢â?¬Â¢Mouth ulcer size >2 mm but <7mm at easily accessible location in the mouth allowing easy evaluation and treatment.
•Ã¢â?¬Â¢Patients with only one Aphthous wound.
•Ã¢â?¬Â¢Only Ulcers that are present in the following anatomical spots will enrolledin the study: superior and inferior inner lip, inner cheek (buccal) and hard palate (the place of the aphthous will be stated in the Case Report Form).
•Ã¢â?¬Â¢Patients with start of mouth ulceration within 48 hours
•Ã¢â?¬Â¢Patients who agree not to use any other medication for the ulcer during the study period.
•Ã¢â?¬Â¢No clinically significant abnormal finding on Medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems).

•1.Patients with multiple aphthous in the mouth during the visit
•2.The patient with Oral lesion suspected to be malignant
•3.The patient with any Ulcerative oral lesion other than Aphthous stomatitis.
•4.If the patient has undergone any experimental oral intervention within the last 24 hours.
•5.History of alcohol addiction or abuse.
•6.Patient who had participated in any other study within the 90 days of study
•7.Females likely to become pregnant during conducting of the study
•8.Pregnant and Lactating females.
•9.Consumption of tobacco containing products Tobacco and tobacco products (like Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening and throughout the entire study
•10.Consumption of vaping products
•11.Any major illness in the last 03 months or any significant ongoing chronic medical illness.
•12.Evidence of allergy or known hypersensitivity to Liquid Applicator and its components.
•13.History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study check-in of each visit.
•14.Use of any other medications for aphthous ulcer within 01 week prior to screening
•15.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion
•16.Patients with Malignancy or a history of malignancy
•17.Patients with Positive results for HIV or Hepatitis B or C
•18.Immunocompromised patients.

发起方

RAJALAKSHMI HOSPITA