Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.

Inclusion Criteria:

• Age between 18 to 60 years old;
• Skin types: I (light caucasian) or III (light brown);
• Intact skin where the product will be applied;
• Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
• Signature of informed consent form

Exclusion Criteria:

• Pregnancy and lactation

• Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;

• Diseases that cause immune suppression;

• Use of photosensitizing drugs;

• History or photodermatoses activities;

• Personal or family history of photoinduced skin cancer;

• Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;

• Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;

  • Previous participation in a study with the same product under test;
  • Relevant medical history or current evidence of alcohol or other drugs abuse;
  • Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
  • Sponsor's employees involved in the study, or close family member of an employee involved in the study;