Assessment of primary dermal irritability, accumulated dermal irritability, and dermal sensitization (HRIPT)

Medicin Instituto da Pele Ltda0 sitesJuly 28, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Medicin Instituto da Pele Ltda
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 28, 2022

End Date

December 30, 2022

Last Updated

2 years ago

Study Type

Intervention

Investigators

Sponsor

Medicin Instituto da Pele Ltda

Eligibility Criteria

Inclusion Criteria

•Participants of both sexes; age between 18 and 70 years; phototypes: I, II, III and IV (according to the Fitzpatrick adapted scale – Annex 1\); intact test region skin; agreement to comply with the trial procedures and to attend the clinic on the days and times determined for the medical evaluations and for the application and reading of the dressings, understanding, consent and signing the Free and Informed Consent Form (FICT)

Exclusion Criteria

•Participants who have been diagnosed with COVID\-19 in the last 4 weeks or who have symptoms such as fever, dry cough, tiredness, body aches or other discomforts; pregnancy or risk of pregnancy and/or lactation (when female); use of anti\-inflammatory drugs for 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; predicted intense exposure to sunlight or tanning sessions during the study period; forecast of 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 month before the start of the study; cosmetic and/or dermatological treatment on the body within 3 weeks prior to selection; scheduled vaccination during the study period or up to 3 weeks before selection; history of sensitization and irritation to topical product; active skin pathologies (local and/or disseminated) that could interfere with the study results; use of new drugs and/or cosmetics during the study; skin reactivity; 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 in study products (test or comparative products); history of non\-adherence or unwillingness to adhere to the study protocol; employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study, or other conditions deemed by the researcher to be reasonable for disqualification from participation in the study