Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation (DERM EV TOPIC)

Kley Hertz

Status: Completed

Conditions: Skin Irritability

Study type: Observational

Funder types: Industry

Identifiers

NCT02419248

KLEY HERTZ-001

Details and patient eligibility

About

Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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;
• Skin reactivity;
• 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;