To determine the safety and efficacy of liquid applicator for patients with inflammation in mouth and lips.
- Conditions
- Recurrent oral aphthae,
- Registration Number
- CTRI/2020/08/026990
- Lead Sponsor
- RAJALAKSHMI HOSPITAL
- Brief Summary
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|**Study Title**
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 a liquid form, manufactured by Tree of Life Pharma ltd. in human adult, patients with Recurrent Aphthous Stomatitis (RAS).
|**Phase of development**
Final formulation, clinical testing for registration
|**Investigational Medicinal Products**
**Test Product (T):** The product is an Applicator with 2 ampules inside each with a liquid form of active ingredients (after breaking the 1 ampules and mixing the 2 liquids) Trichloro acetic acid 25% and Lidocaine 2% manufactured by Tree of Life Pharma ltd.
|**Objectives**
**Primary Objective:**
To determine the efficacy of the Applicator with the liquid active ingredients Trichloro Acetic Acid 25% and Lidocaine 2% manufactured by Tree of Life Pharma ltd. in Human Adult, Patients with Recurrent Aphthous stomatitis (RAS).
**Secondary objective:**
To determine the safety and tolerability of the medical device. The product is an applicator with active ingredients liquid Trichloro acetic acid 25% and Lidocaine 2% manufactured by Tree of Life Pharma ltd. in Human Adult, Patients with Recurrent Aphthous stomatitis (RAS).
|**Study Design**
An open label, multi-canter, single arm treatment, clinical trial in human adult, patient with Recurrent Aphthous Stomatitis (RAS).
|**Study population**
10 generally healthy, patients with recurrent aphthous stomatitis (RAS) with only 1 aphthous wound will be enrolled in the study.
|**Primary Enrolment criteria**
Demographic data, medical and medication history and this history includes duration, frequency of aphthous ulcer, physical examination includes size of aphthous ulcer, serology, biochemistry, Pain intensity scale(By Visual Analog Scale) and size of the ulcer and photography of the ulcer will be performed prior to study enrolment as baseline and several times during the trial. Diagnosis of Aphthous stomatitis will be made prior to study enrolment.
|**Study duration**
10 days.
Duration will be from enrolment of the patient to until the visit completion day.
|**Dose and Mode of Administration**
The product is an applicator with 2 active ingredients in 2 separate liquid glass ampules: when broken and mixed the final concentration is: Trichloro acetic acid 25% and Lidocaine 2% which will be applied once by touching of the tip of the applicator gently without squeezing the applicator for 10 seconds onto the aphthous ulcer This will be done in the clinical facility under the supervision of the Investigator.
The product is applied by turning the pen-like device upside down while the tip sponge upwards - faces the ceiling then firmly pressing on the pen-like device in the designated area in order to break the 2 ampoules that are positioned inside the pen cylinder and shake the pen several times gently in a motion from 12 o’clock to 6 o’clock in order to mix the 2 liquids while the pen is still upside down with the tip facing upwards, then turning the pen with the sponge facing the floor downwards slowly and waiting for the mixed red liquid to drop and fill the sponge with gravity and then when the tip is all reddish applying once with no force for 10 seconds to the wound. A crust over the aphthous will appear after approximately 1 day and healing will start naturally.
Fluids are restricted for 01 hour post application.
***Note:*** Preliminary procedures including signing the ICF will be done on the same day.
|**Evaluation Schedule**
Totally 04 visits.
· Visit 01:Screening and enrolment (Day 01)
· Visit 02: Follow up Visit (Day 03)
· Visit 03: Follow up visit (Day 07)
· Visit 04: End of study visit (Day 10)
|**Patients Safety Measures**
· Biochemistry and serology will be done on the day of screening.
· At every visit, blood pressure, radial pulse rate, oral temperature and wellbeing status will be enquired and recorded.
· The intensity of pain will be assessed during 10 seconds of administration on dosing day (Day 01) in order to determine the pain of the procedure.
· Monitoring of crust formation, size of aphthous ulcer and healing will be monitored on visits 2, 3 and 4 and photographing the area on each visit.
· Monitoring of pain will be monitored on visits 2, 3 and 4 via VAS.
· Another question that would be asked daily:"is the pain stronger or weaker than before the treatment?" This question will be asked on day 02 and day 04 through telephone.
· Monitoring for adverse events will be done throughout the study period.
|**Efficacy assessment**
Primary Efficacy evaluations will be done as follows:
· Follow up visit – Visit 02 –72 hours (Day-03)
· Follow up visit – Visit 03 (Day – 07)
· End of Study -Visit 04 (Day – 10)
Any adverse events would be noted during this evaluation period.
|**Clinical endpoint**
Primary end points· To determine the intensity of pain through VAS (Visual Analogue Scale) during 10 seconds of administration on dosing day (Day 01).
· To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10.
· Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10.
· Another question that would be asked daily:"is the pain stronger or weaker than before the treatment?" This question will be asked on day 02 and day 04 through telephone.
***Secondary end points***
· The assessment of Quality of Life by using a questionnaire subdivided into 3 domains:
-Functional level
-Medication limitation
-Treatment limitation of subjects during treatment period
· Monitoring of Adverse event throughout the study period.
|**Ethical Issues**
The study will be conducted as per the pertinent requirements of the Ethical guidelines for biomedical research on human participants, ICMR (2017), ICH (Step 5) ’Guidance on Good Clinical Practice’, ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP), Declaration of Helsinki (Fortaleza, October 2013), New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) dated 19 Mar 2019 and applicable regulatory requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
- •Adult, non smoking, human above 18 years •Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
- •Mouth ulcer size >2 mm but <7mm at easily accessible location in the mouth allowing easy evaluation and treatment.
- •Patients with only one Aphthous wound.
- •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).
- •Patients with start of mouth ulceration within 48 hours •Patients who agree not to use any other medication for the ulcer during the study period.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) 1.To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) | 2.Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. | 3.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10. 2.Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. 1.To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) | 2.Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. | 3.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10. 3.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10. 1.To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) | 2.Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. | 3.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10.
- Secondary Outcome Measures
Name Time Method N/AP N/AP
Trial Locations
- Locations (2)
ACSR GOVERNMENT COLLEGE
🇮🇳Bangalore, KARNATAKA, India
RAJALAKSHMI HOSPITAL
🇮🇳Bangalore, KARNATAKA, India
ACSR GOVERNMENT COLLEGE🇮🇳Bangalore, KARNATAKA, IndiaMr PhaneendraPrincipal investigator7660801861doddaga.phaneendra@gmail.com