administration intravaginal
Conditions
Interventions
Sponsors
Labterapi Laboratório de produtos naturais EIRELI EPP
Labterapi Laboratório de produtos naturais EIRELI EPP
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy skin in the study region; Age 18 to 65 years; Gender: male and female; Participants with phototypes I, II, III and IV (according to the Fitzpatrick classification); No history of irritation / allergy to the material used in the study; Having signed the Informed Consent Form (ICF); Participants wishing to participate in the study without financial gain. They will be reimbursed for test-related expenses such as transportation and food
Exclusion criteria
Exclusion criteria: Participants who refuse to participate in the study in question. Skin tags in the experimental area that interfere with the evaluation of possible skin reactions; Active dermatoses (local and widespread) that may interfere with the study results; Pregnant or lactating women; History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medicines; Volunteers with a history of allergy to the material used in the study; History of atopy; History of conditions aggravated or triggered by ultraviolet radiation; Carriers of immunodeficiencies; Kidney, cardiac or liver transplantation; Prediction of intense sun exposure or tanning session during the study period; Prediction of bathing in the sea, pool or sauna during the study; Participants who practice water sports; Use of the following systemic topical drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to two weeks before selection; Treatment with acidic vitamin A and / or its derivatives orally or topically within 1 month before the start of the study; Expected vaccination during the study or up to 03 weeks before the study; Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study. Note: Included participants are advised not to change diet, cosmetic and hygiene habits, exercise routine and contraceptive method. Also, not to use products from the same category as the product tested in the experimental region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the absence of primary and accumulated dermal irritation reactions and allergic reactions by sensitization by the investigational products, ensuring the safety of the products to the community. | — |
Secondary
| Measure | Time frame |
|---|---|
| Each participant's feelings of discomfort and clinical signs will be assessed, and if at least 70% of them do not report / experience discomfort / clinical signs, products will be considered safe. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed