Evaluation of irritability and sensitization of a skin cream, through the Contact Test

Not Applicable

• Conditions: ormal State of Health; Epidermis; HP1.007.091

• Registration Number: RBR-8nkqvw4
• Lead Sponsor: Ipclin Instituto de Pesquisa Clínica Integrada Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-10
• Study Completion: 2022-11-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Male and female; Age: 18 to 65 years; Phototype: I to IV; Whole skin of the area

Exclusion Criteria

Participants who refuse to participate in the study in question; Revision marks and experimental area that interfere in the evaluation of reactions of reactions; Active dermatoses (local and disseminated) that may interfere with the study results; Pregnant or lactating women; History of drugs for allergic reactions, purchases or products of sensations of intense and topical use: Volunteers with a history of allergies to the material used in the study; Atopy history; Use of vaginal cream; Participants with a history of allergies and products in the category tested; Recent gynecological surgeries; discharges; History of pathologies aggravated or triggered by ultraviolet radiation; Immunodeficiency carriers; Kidney, heart or liver transplants; Forecast of intense sun exposure or tanning session during the period conducting the study; Forecast to take a bath in the sea, swimming pool or sauna during the study; Participants who play sports; Use of the following systemic topical drugs: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to two weeks before selection; Treatment with acidic vitamin A and/or its oral or topical delivery up to 1 month before the start of the study; Forecast before carrying out study 03; Any condition not mentioned above that may, in the opinion of the investigator, carry out an evaluation of the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to prove, trought the patch test, the absence of primary skin irritation reactions and accumulated and allergic reactions by sensitization by investigative products, if no participant reports/presents discomfort sensations/clinical signs.

Secondary Outcome Measures

Name	Time	Method
It is hoped to guarantee the safety of the products to the community, through the patch test, if no participant reports/presents discomfort sensations/clinical signs.