Consumer Product Safety
Conditions
Interventions
Sponsors
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Intt Comercio, Distribuição, Importação e Exportação de Cosmeticos LTDA
Eligibility
Sex/Gender
Female
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Women; age 18 to 59 years; phototype I to IV; whole skin of the region; occasional user of category products
Exclusion criteria
Exclusion criteria: Skin tags in the experimental area that interfere in the evaluation of possible reactions; pregnant or lactating women; participants with a history of allergy to the material used in the study; atopy history; use of vaginal cream; participants with a history of allergy to products in the tested category; recent gynecological surgeries; discharges; immunodeficiency carriers; kidney, heart or liver transplants; active skin 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 investigational product, an intimate lubricant, in the studied population, after using the products in real conditions of use, through dermatological and gynecological medical evaluation of clinical signs and feelings of discomfort, based on the finding of that none of the participants presented discomfort or clinical signs, considering the product as gynecologically and dermatologically tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to guarantee the safety of the product, an intimate lubricant, to the end users, based on the observation that none of the participants presented discomfort or clinical signs. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Outcome results
None listed