Wounds and injuries
Conditions
Interventions
Sponsors
Ipclin - Pesquisa Clínica Integrada
Vita vert industria e comercio de cosmeticos ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Full skin in the study region (back); Age 18 to 65 years; Gender; male or female, Participants with phototypes I; II; III and IV (according to Fitzpatrick's classification); Absence of irritation allergy history to the material used in the study; Have signed the Term of Free and Informed Consent (TCLE); Participants who want to participate in the study without financial gain. They will only be reimbursed for transportation and food expenses.
Exclusion criteria
Exclusion criteria: Participants who refuse to participate in the study in question; Skin marks in the experimental area that interfere in the evaluation of possible skin reactions (pigmentation disorders; vascular malformations; scarring; increased hairiness; ephelides and nevus in large quantities; sunburn); Dermatoses (local and disseminated) that could interfere with the results of the study; Pregnant women or infants; History of allergic reactions; irritation or intense discomfort feelings to topical products; for health and medicines; Volunteers with a history of allergy to the material used in the study; History of atopy; History of conditions aggravated or triggered by ultraviolet radiation; Immunodeficiency carriers; Kidney; cardiac or hepatic transplanted patients; Intense sun exposure or tanning session up to 15 days prior to initial evaluation; Forecast of intense sun exposure or session of bron during the course of the study; Forecast of bathing; pool or sauna during the study; Participants practicing aquatic sports; Use of the following topical systemic medicinal products; immunosuppressive; antihistaminic; non-hormonal anti-inflammatory drugs; and corticosteroids up to two weeks prior to selection; Treatment with acid vitamin A and or its derivatives via oral or topical use up to 01 month before start of the study; Vaccination prediction during the study or up to 03 weeks before the study; Any condition not mentioned above that in the opinion of the investigator could compromise the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate the absence of the occurrence of reactions of primary and accumulated dermal irritation and of allergic reactions by sensitization by the investigational products, guaranteeing to the community the safety of the products. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and, if at least 70% of the participants do not report / show feelings of discomfort or clinical signs, the product will be considered dermatologically safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| No Secondary Outcomes Expected | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed