Assessment of the safety and efficacy of a nasal spray product.

Not Applicable

• Conditions: ose Diseases; C08.460

• Registration Number: RBR-6vpxz6
• Lead Sponsor: Ipclin - Pesquisa Clínica Integrada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.