Cumulative Irritation Patch Test

NCT01842711 | Completed DMC

• 1 other identifier: CTTA01-010
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Irritation; Sensitization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Allergic Contact Sensitization Potential

  21 days

Eligibility Criteria

• Age: 16 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chattem, Inc.: lead

Study Sites (1)

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, 07004, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Michael Caswell, PhD

  Consumer Product Testing Company

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 30, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

US (1)