Assessment of skin irritability after using a medical device

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

Participants of both sexes aged 18 to 70; phototype: I, II, III and IV; skin in the application region is complete; agreement to follow the trial procedures and attend the clinic on the specified days and times; understanding, consent and signature of the free and informed consent form

Exclusion Criteria

Pregnancy or risk of pregnancy and/or lactation; use of anti-inflammatory drugs 30 days and/or immunosuppressants for up to three months before selection; immunosuppression by drugs or active diseases; decompensated endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days before the assessment or during the study period; expect intense exposure to sunlight or tanning sessions during the study period; provision for bathing in the sea, swimming pool or sauna during the study; practice of water sports during the study; dermographism; use of oral or topical treatment with vitamin A acid and/or its derivatives up to 1 week before the start of the study; aesthetic and/or dermatological treatment on the body within 03 weeks before selection; vaccination scheduled during the study period or up to 3 weeks before selection; history of sensitization, irritation or photosensitization to topical products; active skin pathologies that may interfere with the study results; skin reactivity; use of new medications/cosmetics during the study; previous participation in studies with the same product; congenital or acquired immunodeficiency; relevant medical history or current evidence of alcohol or other drug abuse; known or suspected history of intolerance to any ingredient of the study product; history of lack of adherence or unwillingness to adhere to the study protocol; employees of Medcin or the sponsoring company involved in the study, or an immediate family member of an employee involved in the study

Study & Design

Study Type: Intervention

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prove the absence of irritation reactions (primary and accumulated dermal irritation) and allergy (dermal sensitization) of the investigational product in the population studied through the compatibility test

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes are expected

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Updated 5/29/2023