Other disorders of nose and nasal sinuses
Conditions
Interventions
This is an uncontrolled clinical study to evaluate the dermatological safety of a nasal lubricant. Participants should apply the product according to the method of use described below: Before use, was
dry with clean, soft gauze and reinsert the applicator and the cap. Keep it closed by protecting it.
It is expected that 35 participants, aged 18 to 65 years and phototypes from I to IV (Fitzpatrick's
Device
Sponsors
Ipclin - Pesquisa Clínica Integrada
Labterapi Laboratório de produtos naturais EIRELI EPP
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Female and male. Age 18 to 65 years. Phototype I to IV. Whole skin of the region. Occasional user of category products
Exclusion criteria
Exclusion criteria: Cutaneous marks in the experimental area that interfere in the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scarring, increased hairiness, ephelides and nevus in large quantities, sunburns). Pregnant or nursing mothers. Participants with a history of allergy to the material used in the study. History of atopy. Participants with a history of allergy to cosmetic products of the category tested. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Active cutaneous pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis). Topical use with corticosteroids in the experimental area up to 8 days before the start of the study. Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to verify the acceptability of the research product in the studied population, after the use of the product in real conditions, guaranteeing to the community the safety of the product. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and, if at least 70% of the participants do not report / show feelings of discomfort or clinical signs, the product will be considered dermatologically safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Through the participants' perception it is expected to show that the use of the product offers benefits in terms of nasal lubrication. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed