Burns
Conditions
Interventions
Unicentric, blinded, non-comparative clinical study for the assessment of primary and accumulated dermal irritability and dermal sensitization with the inclusion of 50 participants of both sexes aged
Sponsors
Medicin Instituto da Pele Ltda
Helianto Farmacêutica Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; age between 18 and 70 years; phototypes: I, II, III and IV (according to the Fitzpatrick adapted scale – Annex 1); intact test region skin; agreement to comply with the trial procedures and to attend the clinic on the days and times determined for the medical evaluations and for the application and reading of the dressings, understanding, consent and signing the Free and Informed Consent Form (FICT)
Exclusion criteria
Exclusion criteria: Participants who have been diagnosed with COVID-19 in the last 4 weeks or who have symptoms such as fever, dry cough, tiredness, body aches or other discomforts; pregnancy or risk of pregnancy and/or lactation (when female); use of anti-inflammatory drugs for 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; predicted intense exposure to sunlight or tanning sessions during the study period; forecast 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 month before the start of the study; cosmetic and/or dermatological treatment on the body within 3 weeks prior to selection; scheduled vaccination during the study period or up to 3 weeks before selection; history of sensitization and irritation to topical product; active skin pathologies (local and/or disseminated) that could interfere with the study results; use of new drugs and/or cosmetics during the study; skin reactivity; 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 products); 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, or other conditions deemed by the researcher to be reasonable for disqualification from participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find absence of potential for irritation and allergy in the population studied through the assessment of primary and cumulative dermal irritation and dermal sensitization, using methodology established in the literature and widely used in clinical trials of topical compatibility. The significance level considered to test the absence of positivity was 95% and the power of the test was 80% | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medicin Instituto da Pele Ltda
Outcome results
None listed