Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Immune System Diseases

+ Hypersensitivity

From 16 to 79 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorChattem, Inc.
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01842711
Principal SponsorChattem, Inc.
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

224 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesHypersensitivity

Criteria

8 inclusion criteria required to participate
Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form
Subjects must be aged 16 to 79 years, inclusive
Subjects must be capable of understanding and following directions
Subjects must be considered reliable
Show More Criteria
4 exclusion criteria prevent from participating
Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial
Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial
Subjects judged by the PI to be inappropriate for the trial
Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Consumer Product Testing Company, Inc.

Fairfield, United StatesOpen Consumer Product Testing Company, Inc. in Google Maps
CompletedOne Study Center