Cumulative Irritation Patch Test

Completed

• Conditions: Allergy; Irritation; Sensitization

• Registration Number: NCT01842711
• Lead Sponsor: Chattem, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-04
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-29
• Last Update Submitted: 2013-04-29
• Study First Posted: 2013-04-30
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary or Cumulative Irritation Potential of the skin	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 Outcome Measures

Name	Time	Method
Allergic Contact Sensitization Potential	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.

Trial Locations

Locations (1)

Consumer Product Testing Company, Inc.; 🇺🇸 Fairfield, New Jersey, United States