Healthy volunteers
Conditions
Interventions
Clinical study to evaluate the safety of an investigational cosmetic product, an intimate lubricant. The inclusion of 60 participants is expected, aged 18 to 59 years and phototypes I to IV (according
Sponsors
IPCLIN - Instituto de Pesquisa Clínica Integrada Ltda
IPCLIN - Instituto de Pesquisa Clínica Integrada Ltda
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Full skin on the back;age from 18 to 59 years old;male and female;participants with phototypes I, II, III and IV according to the Fitzpatrick classification;absence of history of irritation and allergy to the material used in the study;have signed the free and informed consent form;participants who wish to participate in the study without financial profit
Exclusion criteria
Exclusion criteria: Participants who refuse to participate in the study in question;skin marks in the experimental area that interfere with the assessment of possible skin reactions,such as scars,increased hairiness,large quantities of ephelides and nevus and sunburn;active dermatoses that could interfere with the study results;pregnant or breastfeeding women;history of allergic reactions,irritation or intense sensations of discomfort to topical products such as cosmetics and medicines;volunteers with a history of allergy to the material used in the study;history of atopy;history of pathologies aggravated or triggered by ultraviolet radiation;intense sun exposure or tanning session up to 15 days before the initial assessment;expected intense sun exposure or tanning session during the study period;plan to take a swim in the sea, swimming pool or sauna during the study;participants who practice water sports;use of the following systemic topical medications:immunosuppressants,antihistamines,non-steroidal anti-inflammatory drugs,and corticosteroids up to two weeks before the selection;treatment with acid vitamin A and/or its derivatives orally or topically up to 1 month before the start of the study;anticipation of vaccination during the study or up to 3 weeks before the study,so as not to correlate the possible side effects of the vaccine with the study in question;any condition not mentioned above that,in the opinion of the investigator,may compromise the evaluation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to prove the absence of primary and accumulated dermal irritation reactions and allergic reactions due to sensitization by the investigational product, an intimate lubricant, ensuring the safety of the product to the community. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to guarantee end users the safety of the investigational product, an intimate lubricant, based on the finding 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