Evaluation of irritability and sensitization of health products, through the contact test.

Not Applicable

• Conditions: Administration Intravaginal; E02.319.267.120.500

• Registration Number: RBR-3k6982
• Lead Sponsor: Makelab Consultoria Eireli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women; Age: 18 to 65 years; Phototype: I to IV; Whole skin of the region; Occasional user of products of the category

Exclusion Criteria

Participants who refuse to participate in the study in question; Skin marks in the experimental area that interfere in the evaluation of possible skin reactions; Active dermatoses (local and disseminated) that may interfere with the results of the study; 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; Background of atopy; Use of vaginal cream; Participants with a history of allergy to products in the tested category; Recent gynecological surgeries; Discharges; History of pathologies aggravated or triggered by ultraviolet radiation; Immunodeficiency sufferers; Kidney, heart or liver transplantation; Forecast of intense sun exposure or tanning session during the period
conducting the study; Forecast of bathing in the sea, pool or sauna during the study; Participants who practice water sports; Use of the following medications for systemic topical use: 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 up to 01 month before the beginning of the study; Vaccination forecast during the study or up to 03 weeks before the study; Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is hoped to prove the absence of primary skin irritation reactions and<br>accumulated and allergic reactions by sensitization by investigative products.

Secondary Outcome Measures

Name	Time	Method
It is hoped to guarantee the safety of the products to the community.