Evaluation of irritability and sensitization of cream for Psoriasis through the Contact Test
- Conditions
- Psoriasis
- Registration Number
- RBR-2j4j5gr
- Lead Sponsor
- TCI BIOTECNOLOGIA LTDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Male and female; Age: 18 to 59 years; Phototype: I to IV; Whole skin of the area;
Participants who refuse to participate in the study; Skin marks in the experimental area that interfere in the evaluation of possible skin reactions; Active dermatoses (local and disseminated) that may interfere with the results of the study; Pregnant or lactating women; Historic of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medicines; Volunteers with a history of allergy to the material used in the study; Background of atopy; Use of vaginal cream; Participants with a history of allergy to products in the tested category; Recent gynecological surgeries; Discharges; History of pathologies aggravated or triggered by ultraviolet radiation; Immunodeficiency sufferers; Kidney, heart or liver transplantation; Forecast of intense sun exposure or tanning session during the period of the study; Forecast of bathing in the sea, pool or sauna during the study; Participants who practice water sports; Use of the following medications for systemic topical use: 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 up to 01 month before the beginning of the study; Vaccination forecast 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to prove, trought the patch test, the absence of primary skin irritation reactions and accumulated and allergic reactions by sensitization by investigative products, if no participant reports/presents discomfort sensations/clinical signs.
- Secondary Outcome Measures
Name Time Method It is hoped to guarantee the safety of the products to the community, through the patch test, if no participant reports/presents discomfort sensations/clinical signs.