Accidental Injuries
Conditions
Interventions
Single-center, single-blind, non-comparative clinical study to evaluate primary and accumulated dermal irritability and dermal sensitization, with the aim of proving the topical compatibility of the m
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 years; phototype: I, II, III and IV; intact skin in the application region; agreement to follow the trial procedures and to attend the Center on the days and times determined for medical evaluations and for application and reading of dressings; understanding, consenting to and signing the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy/lactation; use of anti-inflammatory drugs 30 days and/or immunosuppressive drugs for up to three months prior to selection; immunosuppression due to drugs or active diseases; decompensated endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days prior to the assessment or during the study period; anticipated sea bathing, 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 prior to the start of the study; aesthetic and/or dermatological treatment on the body within 03 weeks prior to selection; scheduled vaccination during the study period or up to 03 weeks prior to selection; history of sensitization, irritation or photosensitization to medical devices; active skin pathologies that may interfere with the results of the study; skin reactivity; use of new medications during the study; previous participation in studies with the same physician; congenital or acquired immunodeficiency; relevant clinical history or current evidence of alcohol or other drug abuse; known history or suspected intolerance to any ingredient of the study medical device; 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 participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify 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