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

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ClinicalTrials.gov Identifier: NCT03007498
Recruitment Status : Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
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 ]


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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.
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;

Responsible Party: Kley Hertz S/A
ClinicalTrials.gov 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