RBR-897tzz6
Not yet recruiting
Not Applicable
Clinical study to evaluate the safety of the investigational product mint-flavored denture fixative cream through the Assessment of Acceptability in the oral mucosa and Perceived Efficacy under normal conditions of use
Kosmoscience Ciência e Tecnologia Cosmética Limitada0 sitesJuly 29, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kosmoscience Ciência e Tecnologia Cosmética Limitada
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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