Assessment of the potential for primary irritation and skin sensitization without the use of four etectrodes

Not Applicable

• Conditions: Healthy humans, skin irritation test and contact dermatitis (skin sensitization); diseases of the skin and connective tissue.; E05.940.790.500; C17.800.174.255

• Registration Number: RBR-66j5yf
• Lead Sponsor: 3M do Brasil Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

healthy subjects; intact skin on test site; agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments; ability of giving consent for participation in the study; aged from 18 to 70 years old; phototype (Fitzpatrick): I to IV; any gender.

Exclusion Criteria

pregnancy or breastfeeding; any skin marks on the test site that might interfere with the assessment of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased pilosity, and great amounts of ephelides and nevus, sunburns); active dermatosis (local or disseminated) that might interfere with the results of the study; antecedents of allergic reactions, irritation or sensation of intense discomfort to topical products: cosmetics, health products or medications; atopy antecedents, (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); discomfort sensation with temperature changes (too hot/too cold) and/or when you are in the air conditioner; subjects with history of allergy to the materials used in the study; history of pathologies aggravated or triggered by ultraviolet radiation; subjects suffering from immunodeficiencies; intense exposure to sunlight or to sun tanning sessions up to 15 days before the initial assessment; intention of being intensely exposed to sunlight or to sun tanning sessions during the study period; forecast to sea bath, to go to the pool or bathtub during the study; subjects who practice water sports; dermographism;aesthetic and/or dermatological treatment performed on the body within 03 weeks before selection; use of the following topical or systemic medications: immunosuppressant drugs, antihistamines, non-hormonal antiinflammatory drugs, and corticosteroids up to 2 weeks before selection; in case of deposit corticosteroids, up to 1 month before selection; oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the study started; forecast of vaccination during the study or up to 03 weeks before the study; be currently taking part or have already participated in another clinical study which was concluded less than 07 days before selection, if the previous study is an in-use study; be currently taking part or have already participated in another clinical study which was concluded less than 21 days if the previous study was a Compatibility study or an Adverse Reaction Investigation; any conditions not mentioned above which the investigator finds compromising to the evaluation of the study; history of lack of adherence or unwillingness to adhere to the study protocol;
professionals who are directly involved in the performance of the current protocol as well as their relatives.

Study & Design

• Study Type: Intervention
• Study Design: Not specified