Nose Diseases
Conditions
Interventions
This is a clinical study to evaluate the safety and efficacy of nasal spray. It is expected that 80 participants, aged between 18 and 65 years, of both sexes and phototypes from I to IV (according to
Device
S01.2
Sponsors
Ipclin - Pesquisa Clínica Integrada
Master ind. e com. de produtos odontológicos e farmacêuticos ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age: 18 to 65 years Female and male. Full skin in the study region (nose). Phototypes I to IV. Participants who agree to adhere to the procedures and requirements of the study and to attend the Institution on the days and times determined for the evaluations. Participants who have the capacity to consent to their participation, signing the Informed Consent Term (TCLE). Participants who agree not to use products of the same category during the conduct of this research. Participants who have not participated in similar studies for at least 2 months prior to the study.
Exclusion criteria
Exclusion criteria: Diseases or medications that may directly interfere with the study or endanger the health of the research participant, according to the physician responsible for including study participants. Immunodeficiencies. Renal, cardiac or hepatic transplanted. Erythema solar in the study region due to intense sun exposure 1 month before the study. Current use of the following medicines: corticoids, antihistamines, immunosuppressants, retinoids, anti-inflammatories. Participants who refuse to participate in the study in question. Any condition that could interfere with the evaluations according to the investigator of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to prove, under normal conditions of use, whether the product under investigation is capable of promoting improvement of nasal hydration. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and an otorhinolaryngologist, if at least 70% of the participants do not report / present feelings of discomfort or clinical signs, the product will be considered a dermatologist and a safe otorhinolaryngologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to safety, it will be possible to evaluate the participants' perception of the effectiveness of the product for nasal hydration in their end users. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed