Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation

Completed

• Conditions: Skin Irritability

• Registration Number: NCT02419248
• 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

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• 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	40 days