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Completed

NCT Number: NCT01842711

Cumulative Irritation Patch Test

A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical agent or agents have the potential to cause contact irritation or contact allergy in the skin. Allergy is only elicited in immunologically competent individuals who have become sensitized through exposure to the chemical agent at a sufficient concentration and for a sufficient duration of time.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases Irritation Sensitization

Age range

16 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, 07004, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must not have any visible skin disease that might be confused with a skin reaction to the test trial;
  • Subjects must not be participating in another clinical trial at this facility or any other facility;
  • Subjects must be willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
  • Subjects must understand and execute and Informed Consent Form;
  • Subjects must be capable of understanding and following directions;
  • Subjects must be considered reliable;
  • Subjects must be aged 16 to 79 years, inclusive;
  • Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form.

Exclusion criteria

  • Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial;
  • Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial;
  • Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products;
  • Subjects judged by the PI to be inappropriate for the trial.

Treatment and study plan

Primary outcomes

  1. Primary or Cumulative Irritation Potential of the skin

    Time frame: 21 days

    This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation.

Secondary outcomes

  1. Allergic Contact Sensitization Potential

    Time frame: 21 days

    After the repeated application period of the test material, a rest period will be employed. The test material will be applied to a naïve site and then will be evaluated by a trained assessor with a predetermined scale for skin irritation.

Sponsors and collaborators

Lead sponsor

Chattem, Inc.

Industry

Registry information

Official study title

Exclusive Cumulative Irritation Patch Test (21 Day) With Challenge Patch Application

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2013
Registry last updated
Apr 30, 2013

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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