Accidental Injuries
Conditions
Interventions
Sponsors
Medcin Instituto da Pele LTDA
Helianto Farmacêutica Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; aged 18 to 70 years; skin of the application region integrates; agreeing to follow the test procedures and to attend the clinic on the days and times determined for medical evaluations and for application and reading of dressings; understanding, consent and signing of the Free and Informed Consent Term (ICF)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and/or lactation; use of anti-inflammatory drugs and/or immunosuppressive drugs for up to three months before selection; immunosuppression by drugs or active disease; 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 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 week before the start of the study; aesthetic and/or dermatological treatment on the body within 03 weeks before selection; scheduled vaccination during the study period or up to 3 weeks before selection; history of sensitization, irritation or photosensitization to topical products; active skin pathologies (local and/or disseminated) that may interfere with the study results; skin reactivity; use of new drugs/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 in study products (test or comparative product); 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; other conditions considered by the researcher as reasonable for disqualification from participating 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 studied population through the comparability 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