Patch Tests
Conditions
Interventions
Controlled, single-center clinical trial to evaluate primary and accumulated skin irritation and skin sensitization through maximized and controlled applications of an investigational intimate lubrica
Sponsors
Kosmoscience Ciência e Tecnologia Cosm Imp Exp LTDA
Kosmoscience Ciência e Tecnologia Cosm Imp Exp LTDA
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy research participant; age range between 18 and 70 years old; gender: female and male; phototype: I to IV. fitzpatrick classification; agreement not to wet the area during the entire test period; understand the test procedures and agree to adhere to the study requirements; absence of inflammatory dermatoses or tattoos at the application site; signing of the Free and Informed Consent Form (TCLE)
Exclusion criteria
Exclusion criteria: Pregnancy, lactation; presence of localized or generalized dermatological diseases; presence of active inflammatory dermatoses in the test region; frequent exposure to the sun or tanning beds; have participated in an allergenicity study within a period of less than four weeks from the start of the study; research participants with a history of allergy to the material used in the study; history of atopy; history of pathologies aggravated or triggered by ultraviolet radiation; people with immunodeficiencies; forecast of intense sun exposure or tanning session during the study period; anticipated bathing in the sea, swimming pool or sauna during the study; research participants who practice water sports; dermographism; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to 2 weeks before selection; treatment with acid vitamin A and/or its derivatives orally or topically up to 1 month before the start of the study; aesthetic and/or dermatological body treatment up to 3 weeks before selection; expected vaccination during the study or up to 3 weeks before the study; any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study; history of lack of adherence or unwillingness to adhere to the study protocol; professionals directly involved with the research center and sponsor in carrying out this protocol and their families; be participating in another study at the time; any condition that, in the researcher's opinion, could compromise the study (describe)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Evaluate the potential for Primary Dermal Irritability, Accumulated Dermal Irritability and Dermal Sensitization of products through the application of Patch Test, proving the product's safety for topical use | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactAna Tabarini Alves Pinheiro
Kosmoscience Ciência e Tecnologia Cosmética Importação Exportação LTDA
Outcome results
None listed