Repression-Sensitization
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. Phototype I, II, III, and IV according to the Fitzpatrick scale. Intact skin in the application area. Agreement to follow the trial procedures; attendance at the Center on the specified days and times for medical evaluations, applications, and patch readings. Understanding, consent, and signing of the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy/lactation. Use of anti-inflammatory drugs in the last 30 days and/or immunosuppressive drugs up to three months before selection. Immunosuppression due to drugs or active diseases. Uncompensated endocrinopathies. Personal history of atopy. Intense sun exposure or tanning sessions up to 15 days before the assessment or during the study period. Planned exposure to sea baths, swimming pools, or saunas during the study. Practice of water sports during the study. Dermatographism. Use of oral or topical treatment with vitamin A acid and/or derivatives up to 1 month before the study start. 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 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 clinical history or current evidence of alcohol or other drug abuse. Known or suspected history of intolerance to any ingredient of the study product. History of non-adherence or unwillingness to adhere to the study protocol. Medcin employees or sponsor company employees involved in the study or immediate family members of an employee involved in the study. Other conditions considered reasonable by the researcher for disqualification from study participation being described in the observation section of 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