Assessment of Primary and Accumulated Irritation Potential, Skin Sensitization Potential and Skin Allergy and Toxicity Potential by Ultraviolet Light Accompanied by a Dermatologist for the Gel Cream Product
- Conditions
- HypersensitivityN06.850.210
- Registration Number
- RBR-74b44vf
- Lead Sponsor
- Kosmosciense Ciência e Tecnologia Cosm Imp Exp Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Healthy research participant. Age range between 18 and 70 years. Gender: female and male. Phototype (Fitzpatrick): I to IV. Agree to adhere to the requirements of the study in combating the COVID-19 pandemic, through preventive measures: use a mask according to WHO guidelines, use the mask when traveling to the research center and during the study procedures, maintain the social distancing; wash your hands frequently with soap and/or alcohol gel and attend the research center only at scheduled times to avoid crowds. Agreement not to wet the site during the entire test period. Understand the test procedures and agree to adhere to the study requirements. Absence of inflammatory dermatosis or tattooing at the application site. Signature of the Free and Informed Consent Term (TCLE)
Pregnancy, lactation. Participant who belongs to the risk group for COVID-19, that is, with chronic cardiovascular, kidney and respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group. Use of corticosteroids, antihistamines and/or anti-inflammatories. History of allergy to cosmetic products and/or health products. Presence of localized or generalized dermatological diseases. Presence of active inflammatory dermatoses in the test region. Presence of nevic lesions in the test region. Personal or family history of skin cancer. Use of topical or systemic photosensitizing medication. History of phototoxic or photoallergic reactions. Photo-induced pathologies, such as Lupus Erythematosus, Recurrent Herpes Simplex, History of dermatoses caused by light, such as solar urticaria and polymorphous light eruption. Frequent exposure to the sun or tanning beds. Have participated in an allergenicity study within a period of less than four weeks from the beginning of the study. Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevi in large numbers, sunburn). Active dermatoses (local or disseminated) that may interfere with the study results. History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics, health products or medicines. Research participants with a history of allergy to the material used in the study. Background of atopy. History of pathologies aggravated or triggered by ultraviolet radiation. Immunodeficiency patients. Intense sun exposure or tanning session up to 15 days before the initial assessment. Prediction of intense sun exposure or tanning session during the study period. Provision of bathing in the sea, swimming pool or sauna during the study. Research participants who practice water sports. Dermographism. Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to 2 weeks before selection. Treatment with acidic vitamin A and/or its derivatives orally or topically up to 01 month before the start of the study. Body aesthetic and/or dermatological treatment up to 03 weeks before selection. Prediction of vaccination 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. History of non-compliance or unwillingness to adhere to the study protocol. Professionals directly involved in carrying out this protocol and their families. Be participating in some other study at the time. Any condition that, in the opinion of the researcher, could compromise the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the potential occurrence of skin hypersensitivity, through dermal contact irritation, dermal sensitization and allergic reactions due to ultraviolet irradiation at the exposed site in contact with the product
- Secondary Outcome Measures
Name Time Method o secondary outcomes expected