Skin
Conditions
Interventions
Sponsors
Medicin Instituto da Pele Ltda
Helianto Farmacêutica Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes aged 18 to 70 years; Phototype: I, II, III and IV (according to adapted scale); Skin of the application region integrates; Agreeing to follow the test procedures and to attend the clinic on the days and times determined for medical evaluations and for application and reading of dressings; Understanding, consent and signing of the Free and Informed Consent Term (ICF)
Exclusion criteria
Exclusion criteria: Participants who have been diagnosed with COVID 19 in the last 4 weeks or who have symptoms of fever, dry cough, tiredness, body aches or other discomforts; Pregnancy or risk of pregnancy and/or lactation (when women); Use of anti-inflammatory drugs and/or immunosuppressive drugs for up to three months before selection; Immunosuppression by drugs or active disease; Decompensated endocrinopathies; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the assessment or during the study period; Expect intense exposure to sunlight or tanning sessions during the study period; Provision of bathing in the sea, swimming pool or sauna during the study; Practice of water sports during the study; Dermographism; Use of oral or topical treatment with vitamin A acid and/or its derivatives up to 1 week before the start of the study; Aesthetic and/or dermatological treatment on the body within 03 weeks before selection; Scheduled vaccination during the study period or up to 3 weeks before selection; History of sensitization, irritation or photosensitization to topical products; Active skin pathologies (local and/or disseminated) that may interfere with the study results; Skin reactivity; Use of new drugs/cosmetics during the study; Previous participation in studies with the same product; Congenital or acquired immunodeficiency; Relevant medical history or current evidence of alcohol or other drug abuse; Known or suspected history of intolerance to any ingredient in study products (test or comparative product); History of non-adherence or unwillingness to adhere to the study protocol; Employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study; Other conditions considered by the researcher as reasonable for disqualification from participating in the study. If yes, it should be described under observation in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Confirm the absence of stress and allergy potential in the studied population through the evaluation of primary and cumulative thermal stress and dermal sensitization;Outcome found 1: No potential for Primary Dermal Irritation was observed. of Accumulated Dermal Irritation and of Dermal Sensitization. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medicin Instituto da Pele Ltda
Outcome results
None listed