Accidental Injuries
Conditions
Interventions
Sponsors
Medcin Instituto da Pele LTDA
Helianto Farmacêutica Ltda
Universidade São Francisco
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medcin Instituto da Pele LTDA
Outcome results
None listed