Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation (DERM EV TOPIC)
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ClinicalTrials.gov Identifier: NCT03007498
Recruitment Status : Unknown
Verified December 2016 by Kley Hertz S/A. Recruitment status was: Not yet recruiting
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.
Age between 18 to 70 years old;
Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
intact skin where the product will be applied
Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
Signature of informed consent form
Pregnancy and lactation
Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
Diseases that cause immune suppression;
Personal history of atopy;
History of sensitisation and irritability to topical products;
Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
Use of new drugs and/or cosmetics during the experiment;
Previous participation in a study with the same product under test;
Volunteers who have congenital or acquired known immunodeficiency;
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;