Hypersensitivity
Conditions
Interventions
A group of 35 healthy research subjects will be instructed to use a product daily, applying it to the dorsal region of the arms. The health product used in this study consists of substances known and
Sponsors
Kosmosciense Ciência e Tecnologia Cosm Imp Exp Ltda
Kosmosciense Ciência e Tecnologia Cosm Imp Exp Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age group between 18 and 70 years old. Female or male sex. Phototype (Fitzpatrick): I to VI. Have intact skin in the application region. Agree to adhere to the study procedures and requirements: study time, returns (after 21 days) to the laboratory to carry out the study procedures, home use of the product under investigation, filling in the use diary, not changing habits during the period of the study. Agree to adhere to the requirements of the study in combating the COVID-19 pandemic, through preventive measures: use a mask in accordance with WHO guidelines, use the mask while traveling to the research center and during study procedures, maintain social distancing, wash your hands frequently with soap and/or alcohol gel and attend the research center only at scheduled times to avoid crowds
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women, Participant who belongs to the risk group for COVID-19, that is, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the investigator judges as belonging to the risk group, Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular, malformations, scars, increased hairiness, freckles and warts in large numbers, sunburn), Presence of dermatoses or active skin lesions (local and/or disseminated) in the study region. History of ineffectiveness, allergic reactions, irritation or feeling of intense discomfort to topical products. Prediction of vaccination during the study or up to 3 weeks before the study. History of pathologies aggravated or triggered by ultraviolet radiation. Use of non-steroidal anti-inflammatory drugs, corticoids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study. Aesthetic or dermatological body treatment up to 4 weeks before the study. Hormonal treatments not stable in the last 3 months, if applicable. Hyperpigmentation associated with the use of drugs such as tetracycline, phenothiazides or amiodarone. Hyperpigmentation associated with photosensitivity. Actinic lichen planus. People directly involved in carrying out this study and their family members. Participating in another study. History of non-adherence or unwillingness to adhere to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the potential occurrence of cutaneous hypersensitivity, through sensations of discomfort and irritative or allergenic cutaneous reactions resulting from the use of the investigational product, applied in skin under normal conditions of use, with initial and final clinical evaluations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactLuciana Vivo
Laboratório Tayuyna Ltda
Outcome results
None listed