Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: AphtoFix®: Cream will be applied by squeezing a small amount of cream on the tip of the finger and to be applied on affected area using a swiping
action to ensure that the cream covers
Sponsors
Bonyf AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with 18 – 65 years of age (both inclusive). 2. Subjects having mouth ulcer size >2 mm in locations for easily accessible for evaluation and treatment. 3. Subject with time of onset of mouth ulceration within 48 hours. 4. Subject who agreed, not to use any other medication to treat mouth ulcer during study period. 5. Subject willingness to comply with the study schedule and procedures. 6. Subject / legally acceptable representative (LAR) of subject willing to sign and date written informed consent to participate in the study. However, if the subject/LAR of subject is illiterate, the impartial witness would sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergy for content present in AphtoFix® 2. Subjects with any invasive dental procedures within 2 weeks prior to screening visit. 3. History of uncontrolled chronic disease (e.g. chronic liver disease, chronic renal disease) 4. Use of any other medication to treat mouth ulcer in current episode. 5. Participation in any other clinical study during last 30 days. 6. Subject with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 7. Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Ulcer size reduction. - Reduction in number of ulcers. - Pain reduction by assessing pain intensity.Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of ulcer (Days need for complete healing). - Number and frequency of application. - Quality of life evaluation using mouth ulcer QOL Questionnaire.Timepoint: 14 Days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed