Skin
Conditions
Interventions
The study will treat 70 volunteers for 39 data and consists of three stages: Primary Dermal Irritability, Accumulated Dermal Irritability and Dermal Sensitization, as described below: 1 PRIMARY DERMAL
Sponsors
INFAN - Indústria Química e Farmacêutica Nacional
INFAN - Indústria Química e Farmacêutica Nacional
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; Age between 18 to 65 years; Phototypes: I, II, III and IV; Skin of the whole test region; Agreement to obey the trial procedures and attend the clinic on the days and times determined for medical evaluations and for application and reading of the dressings; Understand, consent and sign the Free and Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and / or lactation; (when women); Background atopic or allergic 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 and HIV; 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, pool or sauna during the study; Water sports practice during the study; 10) 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, health products that are not part of the participant's routine 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 evaluating physician as reasonable for the disqualification from participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the appearance of possible skin lesions after application of the product in the demarcated area. Injuries will be classified as described below: a) Absent lesion: will be considered negative or zero degree; b) Mild erythema: will be considered doubtful or grade 1; c) Clear erythema: will be considered positive or grade 2; d) Erythema plus edema and papules: will be considered highly positive or grade 3; e) Erythema plus edema plus papules and vesicles: will be considered severely positive or grade 4. The product is expected not to induce injury above grade 1 in more than 5% of patients. In case of appearance of grade 4 lesions in more than 3 randomized patients, the study will be discontinued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes not expected | — |
Countries
Brazil
Contacts
Public ContactMarcelo Oliveira
INFAN - Indústria Química e Farmacêutica Nacional
Outcome results
None listed