Healthy volunteers
Conditions
Interventions
Initially, participants will be recruited through their profiles in the database based on the criteria informed in the item “Selection of Participants”. Only participants who are suitable to the study
Device
G01.358.500.505.650.891
Sponsors
INFAN - Indústria Química e Farmacêutica Nacional
INFAN - Indústria Química e Farmacêutica Nacional
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Male and female participants; Age group between 18 and 70 years; Be in agreement not to change your habits of using health products, including hygiene; Skin intact in the test region; Agreement to follow the trial procedures and attend the clinic on the days and times determined for medical evaluations and for reading the dressings; Understanding, agreement and signing the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and / or lactation; (when women); Atopic or allergic background to health products; Use of anti-inflammatory drugs 30 days and / or immunosuppressive for up to three months before selection; Diseases that cause suppression of immunity, such as Diabetes, HIV, etc .; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the evaluation; Prediction of intense exposure to sunlight or tanning sessions during the study period; Prediction of sea baths, swimming pool or sauna during the study; Water sports during the study; Dermographism (property that has the skin of certain individuals to swell and redden in the place where it is streaked by something relatively sharp); Use of oral or topical treatment with vitamin A acid and / or its derivatives up to 1 month before the beginning of the study; Aesthetic and / or dermatological treatment on the body within 03 weeks before selection; Vaccination scheduled during the study period or up to 03 weeks before selection; History of sensitization and irritation to a topical product; Active skin pathologies (local and / or disseminated) that may interfere with the results of the study; Use of new drugs and / or health products during the study; Skin reactivity; Previous participation in studies with the same product; Known history or suspected intolerance to any ingredient in the study products (test or comparative products); History of lack of adherence or unwillingness to adhere to the study protocol; Other conditions considered by the researcher to be reasonable for disqualifying participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the possible appearance of injuries that will be classified as follows: Absent injury - negative (-) – grade zero Light eritema - doubtful - grade 1 Eritema nitido - positive (+) - grade 2 Erythema + edema + pápulas - positive (++) - grade 3 Erythema + edema + pills + vesicles - positive (+++) - grade 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactMarcelo Oliveira
INFAN - Indústria Química e Farmacêutica Nacional
Outcome results
None listed