AllergyNCT01842711
Cumulative Irritation Patch Test
An observational study of Allergy and Irritation, run by Chattem, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Irritation, Sensitization
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, 07004
About this study
Official title: 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.
- Conditions
- Allergy, Irritation, Sensitization
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (1)
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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Caswell, PhD, Principal investigator, Consumer Product Testing Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842711
- Sponsor's protocol ID
- CTTA01-010
- Status last verified
- Apr 2013
- First submitted
- 24 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusive Cumulative Irritation Patch Test (21 Day) With Challenge Patch Application
- ClinicalTrials.gov ID
- NCT01842711
- Acronym / sponsor ID
- CTTA01-010
- Conditions
- Allergy, Irritation, Sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Chattem, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary or Cumulative Irritation Potential of the skin
Time frame: 21 days
This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation.
1 secondary outcome
Allergic Contact Sensitization Potential
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Caswell, PhD principal investigator
Consumer Product Testing Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Irritation, run by Chattem, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary or Cumulative Irritation Potential of the skin (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.