The purpose of this study is to prove the product tested does not cause photoirritation or
photosensitization reactions when exposed to sun light.
Device: Intimate Lubrificant Gel
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Locations near you
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Full eligibility criteria for NCT03015103
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age between 18 to 70 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
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;
All locations for NCT03015103
View full eligibility
Tris trial is registered with FDA with number: NCT03015103. The sponsor of the trial is Kley Hertz S/A and it is looking for 28 volunteers for the current phase.
Official trial title: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
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