Assessment of irritability and sensitization of health products through (patch test)

Not Applicable

• Conditions: administration intravaginal; E02.319.267.120.500

• Registration Number: RBR-22qrch
• Lead Sponsor: abterapi Laboratório de produtos naturais EIRELI EPP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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.