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OpenTrials
Completed

NCT Number: NCT02419248

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

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

Completed

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Evaluation of adverse effects in maximized conditions

    Time frame: 40 days

Sponsors and collaborators

Lead sponsor

Kley Hertz S/A

Industry

Registry information

Acronym: DERM EV TOPIC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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