Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
- Conditions
- Skin Irritability
- Registration Number
- NCT03007498
- Lead Sponsor
- Kley Hertz S/A
- Brief Summary
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
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;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of adverse effects in maximized conditions 60 days
- Secondary Outcome Measures
Name Time Method