Wounds nonpenetrating
Conditions
Interventions
This is a single-center, single-blind, non-comparative clinical study to evaluate primary and cumulative dermal irritation and dermal sensitization, aiming to verify the topical compatibility of the i
skin will be cleaned with a gauze compress and saline solution at the site where the dressings will be applied. Intermediate readings will be performed by the trained clinical research assistant
in case of adverse events, the participant will be referred for dermatological evaluation. Initially, to assess Primary Dermal Irritation, dressings containing the study product will be applied to the
backs, along with the following control areas: dressing with saline solution, dressing with mineral oil, dressing without product application, and adhe
Sponsors
Medcin Pesquisa Clínica Ltda
Medicin Instituto da Pele Ltda
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, according to the adapted Fitzpatrick scale; intact skin in the application area; agreement to follow the trial procedures and 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 informed consent form
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy/lactation; use of anti-inflammatory drugs 30 days prior or immunosuppressive drugs for up to three months before selection; immunosuppression due to active drugs or diseases; decompensated endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period; anticipated sea bathing, swimming pool or sauna during the study; practice of water sports during the study; dermatographism; use of oral or topical treatment with vitamin A acid or its derivatives up to 1 month before the start of the study; aesthetic or dermatological treatment on the body within 3 weeks before selection; scheduled vaccination during the study period or up to 3 weeks before selection; history of sensitization, irritation or photosensitivity to topical products; active skin pathologies that may interfere with the study results; skin reactivity; use of new medications 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 the study product; history of non-adherence or unwillingness to adhere to the study protocol; Medcin or sponsoring company employees involved in the study, or a close family member of an employee involved in the study; other conditions considered by the investigator as reasonable grounds for disqualification from study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the absence of irritation and allergic reactions to the investigational product in the studied population through compatibility testing | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medcin Instituto da Pele LTDA
Outcome results
None listed