Accidental Injury
Conditions
Interventions
Single-center, single-blind, non-comparative clinical study to assess primary and cumulative dermal irritability and dermal sensitization, with the aim of proving the topical compatibility of the inve
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 an adapted scale); Skin of the application region is intact; Agreeing to follow the trial procedures and attend the clinic on the days and times determined for medical evaluations and for applying and reading swabs; Understanding, consent and signature of the Free and Informed Consent Term
Exclusion criteria
Exclusion criteria: Participants who have been diagnosed with COVID 19 in the last 4 weeks or who are experiencing symptoms such as fever, dry cough, tiredness, body aches or other discomforts; Pregnancy or risk of pregnancy and/or lactation (when women); Use of anti-inflammatory drugs 30 days and/or immunosuppressants for up to three months before selection; Immunosuppression by drugs or active diseases; 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 prior to selection; Scheduled vaccination during the study period or up to 03 weeks before selection; History of sensitization, irritation or photosensitivity 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; History of known or suspected intolerance to any ingredient of the study product (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 participation in the study. If yes, it should be described in observation in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prove the absence of irritation reactions (primary and accumulated dermal irritation) and allergy (dermal sensitization) of the investigational product in the population studied through the compatibility test | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes expected | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medicin Instituto da Pele Ltda
Outcome results
None listed