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

NCT ID: NCT02419248

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-07-31

Brief Summary

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

Conditions

Skin Irritability

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kley Hertz S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KLEY HERTZ-001

Identifier Type: -

Identifier Source: org_study_id