Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation (DERM EV TOPIC)

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

Study Overview

• Status: Completed
• Conditions: Skin Irritability

• Study Type: Observational
• Enrollment (Actual): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of adverse effects in maximized conditions	40 days

Collaborators and Investigators

• Sponsor: Kley Hertz S/A

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KLEY HERTZ-001