Rhinitis
Conditions
Interventions
Non-comparative clinical study. The evaluated health product is a Nasal Spray (0.04% sodium hyaluronate and 1% dexpanthenol solution). For this research, up to 37 participants aged 6 months to 2 years
Sponsors
Allergisa Pesquisa Dermato-Cosmetica Ltda
Allergisa Pesquisa Dermato-Cosmetica Ltda
Megalabs Farmacêutica S.A.
Eligibility
Age
6 Months to 3 Years
Inclusion criteria
Inclusion criteria: Healthy pediatric subjects; Intact skin on test site; Agreement of the child'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 child in the study; Children aged from 6 months to 2 years and 11 months; Study subjects of any gender. Subjects presenting phototype (Fitzpatrick) I to IV;Users of products of the same category.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in wetting, hydration, fluidization and hygiene of the nasal mucosa evaluated from the completion of the Perceived Efficacy Questionnaire after the last application of the product at home by the research participants' guardians, descriptions in the participant's diary and medical evaluations after 30 days 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%.;It is expected that the application of the product does not cause 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 pediatrician 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%. | — |
Countries
Brazil
Contacts
Public ContactMariane Martins
Allergisa Pesquisa Dermato-Cosmetica Ltda
Outcome results
None listed