Eligibility |
Inclusion Criteria:
- Agreement to comply with safety guidelines to minimize contamination risks to
COVID-19;
- Agreement to perform a molecular test to detect COVID-19 to enter the study;
- Healthy participants;
- Non-injured skin in the test region;
- Agreement to adhere to the test procedures and requirements and to attend the
institute on the day(s) and at the time(s) determined for the evaluations;
- ability to consent to participation in the study;
- Age from 18 to 59 years;
- Phototype (Fitzpatrick): I to IV;
- All sex.
Exclusion Criteria:
- Participants who belong to the risk group for COVID-19, that is, with diabetes, with
chronic cardiovascular, renal and respiratory problems, immunosuppressed or other
conditions that the doctor deems to belong to the risk group;
- Pregnant or breastfeeding women;
- Skin marks in the experimental area that interfere with the evaluation of possible
skin reactions;
- Active dermatoses;
- Background of allergic reactions, irritation or intense discomfort sensations to
topical use products;
- History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic
conjunctivitis, etc.);
- Sensation of discomfort with temperature changes (too hot/very cold) and/or when in
the air conditioning;
- Participants with a history of allergy to materials used in the study;
- History of pathologies aggravated or triggered by ultraviolet radiation;
- Carriers of immunodeficiencies;
- Intense sun exposure or tanning session up to 15 days before the initial evaluation;
- Prediction of intense sun exposure or tanning session during the course of the study;
- Expected to bathe in the sea, pool or bathtub during the conduct of the study;
- Participants who practice water sports;
- Dermography;
- Aesthetic and/or body dermatological treatment until 03 weeks before the selection;
- Use of the following topical or systemic drugs: immunosuppressants, antihistamines,
non-hormonal anti-inflammatory drugs and corticoids until 2 weeks before selection or,
considering deposit corticoids, the interval shall be 1 month before selection;
- Treatment with acidic vitamin A and/or its derivatives via oral or topical up to 1
month before the start of the study;
- Vaccination during the study or up to 3 weeks before the study;
- Being or having participated in another clinical trial terminated less than 7 days
before selection, if the previous trial is acceptable in use;
- Being or having participated in another clinical trial terminated less than 21 days
before the selection, in case the previous trial is compatible or Adverse Reaction
investigative;
- Any condition not mentioned above that, in the opinion of the investigator, may
compromise the assessment of the trial;
- History of no adherence or unwillingness to adhere to the study protocol;
- Professionals directly involved in the conduct of this protocol and their families.
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