Assessment of acceptance in use and self-assessment under normal use conditions
- Conditions
- RhinitisM01.774.500
- Registration Number
- RBR-6f2q3my
- Lead Sponsor
- Allergisa Pesquisa Dermato-Cosmetica Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Healthy pediatric subjects; Intact skin on test site; Agreement of the pediatric subject's legal guardian to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments; Ability by the guardian of consenting to the participation of the pediatric subject in the study; Aged between 2 and 12 years old; Study subjects of any gender; Subjects presenting phototype (Fitzpatrick) I to IV; Users of products of the same category
Skin pathology on the area of product application;Diabetes; Immunological insufficiency; Current use of the following topical or systemic medications: corticosteroids, immunosuppressant and anti-histaminic drugs; Skin diseases: vitiligo, psoriasis, atopic dermatitis; History of reaction to the category of product tested; Other diseases or medications that might directly interfere with the study or put subject's health under risk
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected that the application of the product does not promote the appearance of adverse events and sensations of discomfort in the nasal mucosa when used under normal conditions of use, based on evaluations with the dermatologist and otorhinolaryngologist after 30 days (T30) of daily use of the product. Exploratory data analysis will be performed (summary tables and graphs). The comparison of the T30 time in relation to the initial time (T0) will be performed using Student's t test, with a confidence level of 95%.<br><br>
- Secondary Outcome Measures
Name Time Method