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

Skin Irritability Clinical Trial

— DERM EV TOPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419248
• Other study ID #: KLEY HERTZ-001
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: November 9, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Kley Hertz S/A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Brazilian Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Skin Irritability

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kley Hertz S/A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of adverse effects in maximized conditions		40 days	Yes