Skin Irritability
Conditions
Brief summary
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
Interventions
None listed
Sponsors
Kley Hertz S/A
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse effects in maximized conditions | 40 days |
Outcome results
None listed