Cumulative Irritation Patch Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Allergy Irritation Sensitization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Caswell, PhD

Role: PRINCIPAL_INVESTIGATOR

Consumer Product Testing Company

Locations

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Consumer Product Testing Company, Inc.

Fairfield, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CTTA01-010

Identifier Type: -

Identifier Source: org_study_id