Stomatitis Aphthous
Conditions
Interventions
Single-center, single-blind, non-comparative clinical study to prove the safety and efficacy in use of the investigational product. The study will be via teleservice (online service – remote) and data
Sponsors
Medcin Instituto da Pele LTDA
Helianto Farmacêutica Ltda
Eligibility
Age
6 Months to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria group I participant of both sexes aged 18 and 60; participants with mouth ulcers; participants with mild gingivitis; participants who use orthodontic appliances and/or removable prostheses; be a user of products in the same category; participants willing to follow the trial procedures, who have a cell phone capable of use and with access to the internet network and are available for telephone contacts and/or via WhatsApp and teleservices, with internet access on the days and times determined for the assessments ; participants willing to attend the Clinical Research Center for evaluations, if necessary; participants must understand and agree to the Free and Informed Consent Form (e-TCLE) and consent to their participation; group II participants of both sexes aged between 6 months and 1 year; participants in the first teething phase; vaccination card (updated and up to date); intact skin of the analysis region; be a user of products in the same category; parents or legal representative willing to follow the trial procedures, who have a cell phone capable of use and with access to the internet network and are available for contact by telephone and/or via WhatsApp and teleservice, with internet access on determined days and times for assessments; parents or legal representative of participants willing to attend the Clinical Research Center for evaluations, if necessary, parents or legal representatives of participants must understand, agree and sign the Free and Informed Consent Form (e-TCLE)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy/lactation (when women) – for group I; use of anti inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection; skin marks in the experimental area that interfere with the assessment of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn); history of allergies to medical products; active skin pathologies and/or lesions (local and/or disseminated) in the assessment area; immunosuppression by drugs or active diseases; decompensated endocrinopathies; relevant or current clinical history of evidence of alcohol or other drug abuse (for group I); known history or suspected intolerance to products in the same category; aesthetic or dermatological treatment in the evaluation area up to 4 weeks before selection; intense sun exposure up to 15 days before the assessment; employees or children of employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study; other conditions considered by the researcher to be reasonable for disqualification from participation in the study; If yes, it should be described in observation in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm, in real conditions of use, the absence of risk of irritation and capture discomfort sensations of the studied population, under criteria of dermatological and pediatric evaluations | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of the investigational product under real conditions of use | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medcin Instituto da Pele LTDA
Outcome results
None listed