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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03007498
Recruitment Status : Unknown
Verified December 2016 by Kley Hertz S/A.
Recruitment status was:  Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Information provided by (Responsible Party):
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.

Condition or disease
Skin Irritability

Study Type : Observational
Estimated Enrollment : 55 participants
Time Perspective: Prospective
Official Title: Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Study Start Date : January 2017
Estimated Primary Completion Date : February 2017

Primary Outcome Measures :
  1. Evaluation of adverse effects in maximized conditions [ Time Frame: 60 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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;

Responsible Party: Kley Hertz S/A Identifier: NCT03007498     History of Changes
Other Study ID Numbers: Kley Hertz 005
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Dermatologic Agents