Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization of a Scar Gel

Inclusion criteria

• Participants of both sexes aged 18 to 70 years;
• Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
• Intact skin in the application area;
• Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
• Understanding, consent, and signing of the Informed Consent Form (ICF).

Exclusion criteria

• Pregnancy or risk of pregnancy/lactation;
• Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
• Immunosuppression due to drugs or active diseases;
• Uncompensated endocrinopathies;
• Personal history of atopy;
• Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
• Plans to bathe in the sea, pool, or sauna during the study;
• Practice of water sports during the study;
• Dermographism;
• Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
• Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
• Scheduled vaccination during the study period or within three weeks prior to selection;
• History of sensitization, irritation, or photosensitization to topical products;
• Active skin conditions (local and/or widespread) that could interfere with study results;
• Skin reactivity;
• Use of new medications during the study;
• Previous participation in studies with the same product;
• Congenital or acquired immunodeficiency;
• Clinically significant or current evidence of alcohol or drug abuse;
• Known or suspected history of intolerance to any ingredient in the study 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 close family members of an employee involved in the study;
• Other conditions deemed reasonable by the researcher for disqualification from study participation. If applicable, this must be noted in the clinical record.

Exclusion criteria

for the Phototest:

• Previous history of conditions exacerbated or triggered by ultraviolet radiation;
• Use of photosensitizing drugs;
• History or presence of photodermatoses;
• Personal or family history of skin cancer.