Healthy volunteers and integrated skin.
Conditions
Interventions
Comparative study of application of different skin protective films in 42 participants for 5 weeks, with each subject receiving the application of all products in demarcated, randomized areas in the b
Other
Sponsors
3M do Brasil Ltda
3M do Brasil Ltda
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Healthy study subjects; intact skin on test site; agreement to adhere to the procedures and requirements of the study and to report to the institute on the day (s) and at the time (s) scheduled for the assessments; ability to give consent for participation in the study; aged from 18 to 75 years old; male / female / both genders; phototype (Fitzpatrick): I to III; signature of the informed consent form by the subject; subjects who respect the conditioning period not applying topical medications, creams or other skin cleansing products in the assessment sites 3 days before visit 02 (D1)
Exclusion criteria
Exclusion criteria: pregnancy or breastfeeding; skin pathology on the area of product application; type 1 diabetes mellitus: insulin-dependent diabetes, presence of complications resulting from diabetes (retinopathy, nephropathy, neuropathy), presence of dermatosis related to diabetes (lipoidic necrobiosis, plantar ulcer, ring granuloma, opportunistic infections); antecedents of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma; immunological insufficiency; use of systemic corticosteroids or immunosuppressant drugs; skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis; any other condition that, in the investigator opinion, might directly interfere with the study or put the subject health under risk; smokers; subjects in menopause or who state being suffering from heat waves; excessive hairiness in the experimental site; current use of the following topical or systemic medications: corticosteroids, immunosuppressant and anti-histaminic drugs; history of reaction to the category of the tested product, creams, skin cleansers, cosmetics, personal care products and/or topical medicines; Participating in another study, having participated in another study in the two weeks prior to the start of the study or intending to participate in another study during the study period; history of sun hypersensitivity (skin defect or damage to sensitive or light-reactive skin); tattoos, scars, spots or other blesmihes on the assessment areas that might interfere with the study assessments; skin marks on the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, sunburn, vascular malformations, scars, increased hairiness, freckles, warts, tattoos and scars); subjects who have applied any topical medications, creams, or other skin cleansers in the assessment sites during the washout period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the product Cavilon No Sitng Barrier Film has greater potential for skin protection and that promotes greater filmogenic effect in relation to each comparative product, through the analysis of images captured by digital camera and corneometry, there is a decrease in durability over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Não são esperados desfechos secundários. | — |
Countries
Brazil
Contacts
Public ContactRenata de Pietri
3M do Brasil Ltda
Outcome results
None listed