Health Product Irritability and Sensitization Assessment through Contact Test
- Conditions
- Artificial toothE06.780.346.875
- Registration Number
- RBR-587ptd
- Lead Sponsor
- Ipclin - Pesquisa Clínica Integrada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Healthy skin in the region of study (back); Age 18 to 65 years; Gender: male or female; Participants with phototypes I, II, III and IV (according to the Fitzpatrick classification); No history of irritation / allergy to the material used in the study; o Have signed the Informed Consent Form (FICF);
Participants wishing to participate in the study without financial gain. They will be reimbursed for test-related expenses such as transportation and food.
Participants who refuse to participate in the study in question.
Skin tags in the experimental area that interfere with the evaluation of possible skin reactions;
Active dermatoses (local and widespread) that may interfere with the study results;
Pregnant or lactating women;
History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medicines;
o 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;
carriers of immunodeficiencies;
Kidney, heart or liver transplantation;
Intense sun exposure or tanning session up to 15 days prior to initial assessment;
Prediction of intense sun exposure or tanning session during the study period;
Prediction of bathing in the sea, pool or sauna during the study;
Participants who practice water sports;
Use of the following systemic topical drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to two weeks before selection;
Treatment with acidic vitamin A and / or its derivatives orally or topically within 1 month before the start of the study;
Expected vaccination during the study or up to 03 weeks before the study;
Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Verify the absence of primary and accumulated dermal irritation reactions and allergic reactions by sensitization by the investigational products, ensuring the safety of the products to the community.<br>The products will be applied as they are over semi-occlusive dressings, with the aid of<br>1 mL disposable syringe. Distilled water will be used as a control. The lodgings will be<br>placed on the right or left back of the participants (second randomization).<br>Each patch can hold up to 30 products, and product positions<br>Investigative control and control of each participant will be maintained throughout<br>the search.<br>The contact test will remain on the participant's skin for 48 hours and be removed.<br>after this time for reading clinical signs and questioning the sensations of<br>discomfort by the dermatologist. After reading, a new patch will be placed,<br>keeping the products in the same position.
- Secondary Outcome Measures
Name Time Method The discomfort sensations and clinical signs of each participant will be evaluated, and if at least 70% of them do not report / have discomfort sensations / clinical signs, the products will be considered safe.