Erythema
Conditions
Interventions
Sponsors
Medcin Instituto da Pele LTDA
Medcin Instituto da Pele LTDA
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes aged 18 to 70 years; skin 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 specified days and times for medical evaluations and for the application and reading of dressings; understanding, consenting to, and signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and/or lactation (for women); use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months prior to selection; immunosuppression due to drugs or active diseases; uncontrolled endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days before evaluation or during the study period; planned intense sun exposure or tanning sessions during the study period; planned sea bathing, swimming, or sauna use during the study; participation in water sports during the study; dermographism; use of oral or topical 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 3 weeks prior to 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 conditions (local and/or widespread) that could interfere with 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 clinical history or current evidence of alcohol or other drug abuse; known history or suspected intolerance to any ingredient of the study products (test or comparator products); history of non-compliance 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 grounds for disqualification from the study; if so, this should be noted in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to demonstrate the absence of primary dermal irritation, cumulative dermal irritation, and dermal sensitization reactions, evaluated at different study phases using the ICDRG scale, including readings at 48 and 96 hours after product application and in untreated areas after the rest period | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional adverse reactions, such as redness or papule formation, are expected to be observed and recorded throughout the study in cases of potential positive readings | — |
Countries
Brazil
Contacts
Public ContactFrancisco Viana da Silva
Semina Indústria e Comércio Ltda
Outcome results
None listed