Eligibility |
Inclusion Criteria:
- 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 the fight against the COVID-19
pandemic, through preventive measures: use a mask according to WHO guidelines; use the
mask while traveling to the research center and during the study procedures; maintain
social distancing; wash hands frequently with soap and/or alcohol gel and go to the
research center only at scheduled times to avoid agglomerations.
- Agree not to wet the site during the entire test period;
- Understand the test procedures and agree to their adherence to the study requirements;
- Absence of inflammatory dermatoses or tattoo at the application site;
- Signing of the Free and Informed Consent Term (FICT).
Exclusion Criteria:
- Pregnancy, lactation;
- Participants with hyperthermia (body temperature greater than or equal to 37.5ÂșC);
- Participants who have been diagnosed with COVID-19 by RT-PCR exam or by the presence
of IgM antibodies in the serology exam, in the last 4 weeks or who are presenting the
following symptoms: dry or productive cough, sneezing, runny nose, body pain ,
headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom
that may be related to covid-19 at the discretion of the investigator;
- Participant who belongs to the risk group for COVID-19, that is, with cardiovascular,
renal and chronic respiratory problems, immunosuppressed or other conditions that the
doctor judges as belonging to the risk group;
- Participants with heart disease (eg, but not limited to: atrial fibrillation,
obstructive coronary artery disease);
- Participants with renal and/or neurological diseases;
- Participants with severe or decompensated lung and/or respiratory diseases;
- Use of corticosteroids, antihistamines and/or anti-inflammatory drugs;
- Presence of localized or generalized skin diseases;
- Presence of active inflammatory dermatoses in the test region;
- 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;
- Research participants with a history of allergy to the material used in the study;
- Atopy history;
- History of pathologies aggravated or triggered by ultraviolet radiation;
- Immunodeficiency carriers;
- Forecast of intense sun exposure or tanning session during the study period;
- Forecast to take a bath in the sea, swimming pool or sauna during the study;
- Research participants who practice water sports;
- Research participants with 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 1
month before the start of the study;
- Aesthetic and/or dermatological body treatment up to 03 weeks before selection;
- 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;
- History of non-adherence 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 moment.
- Any condition that, in the opinion of the researcher, could compromise the study.
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