Cumulative Irritation Patch Test

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

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.

Study Overview

• Status: Completed
• Conditions: Allergy; Sensitization; Irritation

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fairfield, New Jersey, United States, 07004
      • Consumer Product Testing Company, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 240 subjects will be enrolled in the trial so that at least 200 subjects will complete the trial. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to enroll into the trial.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary or Cumulative Irritation Potential of the skin	This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergic Contact Sensitization Potential	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.	21 days

Collaborators and Investigators

• Sponsor: Chattem, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CTTA01-010