Normal State of Health
Conditions
Interventions
It is a subjective, interventional and unicentric clinic for evaluating the safety of the investigational product. The research will be carried out on 60 people of both sexes. The products will be app
Sponsors
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
TCI Biotecnologia Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male and female; Age: 18 to 65 years; Phototype: I to IV; Whole skin of the area
Exclusion criteria
Exclusion criteria: Participants who refuse to participate in the study in question; Revision marks and experimental area that interfere in the evaluation of reactions of reactions; Active dermatoses (local and disseminated) that may interfere with the study results; Pregnant or lactating women; History of drugs for allergic reactions, purchases or products of sensations of intense and topical use: Volunteers with a history of allergies to the material used in the study; Atopy history; Use of vaginal cream; Participants with a history of allergies and products in the category tested; Recent gynecological surgeries; discharges; History of pathologies aggravated or triggered by ultraviolet radiation; Immunodeficiency carriers; Kidney, heart or liver transplants; Forecast of intense sun exposure or tanning session during the period conducting the study; Forecast to take a bath in the sea, swimming pool or sauna during the study; Participants who play sports; Use of the following systemic topical drugs: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to two weeks before selection; Treatment with acidic vitamin A and/or its oral or topical delivery up to 1 month before the start of the study; Forecast before carrying out study 03; Any condition not mentioned above that may, in the opinion of the investigator, carry out an evaluation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to prove, trought the patch test, the absence of primary skin irritation reactions and accumulated and allergic reactions by sensitization by investigative products, if no participant reports/presents discomfort sensations/clinical signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is hoped to guarantee the safety of the products to the community, through the patch test, if no participant reports/presents discomfort sensations/clinical signs. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Outcome results
None listed