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

NCT02419248 | Completed

• 1 other identifier: KLEY HERTZ-001
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/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.

Conditions

Skin Irritability

Outcome Measures

Primary Outcomes (1)

• Evaluation of adverse effects in maximized conditions

  40 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kley Hertz S/A: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11