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Clinical Trials/RBR-10gm45rd
RBR-10gm45rdNot yet recruitingUnknown

ORC_95616_EN23-0748-01_Assessment of primary dermal irritability, cumulative dermal irritability, and dermal sensitization (HRIPT) - HRIPT Human Repeat Insult Patch Test

Medcin Instituto da Pele LTDA0 sitesStarted: May 16, 2024Last updated:
Conditions

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18Y to 70Y (—)

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

Investigators

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