Edentulous arcade
Conditions
Interventions
Sponsors
Kosmoscience Ciência e Tecnologia Cosmética Limitada
Cimed Industria Sociedade Anônima
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age range between 18 and 60 years. Female and male. Phototype (Fitzpatrick): I to VI. Being a user of removable dental prostheses (dentures). Be a user of products of the same category. Agree on procedures and requirements during study use: study time (after 21 days) laboratory to perform investigational product home study procedures, change the product study diary, do not change the study product study diary. Agree to perform facial aesthetic dermatological treatments until the end of the study (21 days), such as: peelings, laser, fillers, use of any unusual suitable products
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. Participant who belongs to the risk group for COVID-19, that is, with cardiovascular, renal and chronic respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group. Presence of dermatoses, active skin lesions (local and/or disseminated) or irritation in the mouth region (internal or external). Expected vaccination during the study or up to 3 weeks before the study. History of oral pathologies. Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study. Be participating in another study in the same application region. History of non-adherence or unwillingness to adhere to the study protocol. Being undergoing dental treatment. Not taking vitamin A or derivatives. Any condition that, in the opinion of the researcher, could compromise the study. (To describe)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1: check the occurrence of discomfort or irritative perioral reactions for up to 21 days of home use. The safety of the investigational product will be verified through the clinical evaluation of the acceptability in the oral mucosa, to confirm the claims: clinically tested. The results of the study may be used to register the product at ANVISA and to prepare technical and advertising material to support its commercialization. The study will be conducted with a Brazilian sample in which 35 research participants will be included;Primary outcome 2: check perceived effectiveness. Subjective techniques for perceived effectiveness will be used in the study. The results of the study may be used to register the product at ANVISA and to prepare technical and advertising material to support its commercialization. The study will be conducted with a Brazilian sample in which 35 research participants will be included | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactCimed Sociedade Anônima
CIMED INDUSTRIA S.A.
Outcome results
None listed