Cumulative Irritation Patch Test

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842711
• Other study ID #: CTTA01-010
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: April 29, 2013
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: Chattem, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 79 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Allergy
• Irritation
• Sensitization

Locations

Country	Name	City	State
United States	Consumer Product Testing Company, Inc.	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Chattem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes