Dermatitis, ContactPhase 4NCT00795951

Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

A Phase 4 study testing T.R.U.E. Test in people with Dermatitis, Contact, run by Allerderm at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18. Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Dermatitis, Contact
What is being tested?: T.R.U.E. Test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Nov 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Children and adolescents 6 to 18 years of age, and in general good health.
Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.

Who cannot join

Topical corticosteroid treatment during the last 7 days on or near the test area.
Systemic treatment with corticosteroids or other immunosuppressive during the last 7 days.
Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
Acute dermatitis outbreak or dermatitis on or near the test area on the back.
Subjects unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Subjects unable or unwilling to comply with multiple return visits.
Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rady Children's Hospital
San Diego, California, 92123

Other trials in United States

About this study

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

Read the detailed description

Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

Conditions: Dermatitis, Contact
Being tested: T.R.U.E. Test
Keywords: allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST
Medical subject headings: Dermatitis, Contact, Dermatitis, Allergic Contact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T.R.U.E. TestBiological
Also called NA no other names
48 hour application of 28 allergens and negative control

Study groups in NCT00795951
Study group	Role	What they receive
TRUE Test panels 1.1, 2.1, 3.1	Experimental	All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control. Receives: Biological: T.R.U.E. Test

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Reactions: Nickel Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Measured: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
Positive Reactions: Neomycin Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Wool Alcohol
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Potassium Dichromate
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Caine Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
Positive Reactions: Fragrance Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Colophony
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Paraben Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Negative Control
Number of subjects with positive reactions recorded at visit 3 and/or visit 4.
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Balsam of Peru
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Ethylenediamine Dihydrochloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
Positive Reactions: Cobalt Dichloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Epoxy Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Carba Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Black Rubber Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Cl+Me-Isothiazolinone
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Quaternium-15
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Mercaptobenzothiazole
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: p-Phenylenediamine
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Formaldehyde
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Mercapto Mix
Number of subjects with positive reactions at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Thimerosal
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Thiuram Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Diazolidinyl Urea
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Imidazolidinyl Urea
Number of subjects with positive reactions at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Budesonide
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Tixocortol-21-pivalate
Number of subjects with positive reactions at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Positive Reactions: Quinoline Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Measured: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Secondary outcomes (61)

Late Reactions: Nickel Sulfate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Neomycin Sulfate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application
Late Reactions: Wool Alcohol
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Potassium Dichromate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Caine Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Fragrance Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Colophony
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Paraben Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Negative Control
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Balsam of Peru
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Ethylenediamine Dihydrochloride
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
Late Reactions: Cobalt Dichloride
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Epoxy Resin
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Carba Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Black Rubber Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Cl+Me-Isothiazolinone
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Quaternium-15
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Mercaptobenzothiazole
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: p-Phenylenediamine
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Formaldehyde
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Mercapto Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Thimerosal
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Thiuram Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Diazolidinyl Urea
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Imidazolidinyl Urea
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Budesonide
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Tixocortol-21-pivalate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Quinoline Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Measured: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Persistent Reactions: Nickel Sulfate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Neomycin Sulfate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Wool Alcohol
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Potassium Dichromate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Caine Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Fragrance Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Colophony
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Paraben Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Negative Control
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Balsam of Peru
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Ethylenediamine Dihydrochloride
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Cobalt Dichloride
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Epoxy Resin
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Carba Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Black Rubber Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Cl+Me-Isothiazolinone
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Quaternium-15
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: p-Phenylenediamine
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Formaldehyde
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Mercapto Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Thimerosal
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Thiuram Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Diazolidinyl Urea
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Imidazolidinyl Urea
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Budesonide
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Tixocortol-21-pivalate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Quinoline Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Mercaptobenzothiazole
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Measured: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Panel Adhesion Evaluation
Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.
Measured: Visit 2 (day 1) prior to panel removal.
Panel Irritation
Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Measured: Visit 2 (day 1) following to panel removal.
Subject Reported Itching and Burning
Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Measured: Visit 2 (day 1) following to panel removal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2009

First posted21 Nov 2008 (estimated)
Study startNov 2008
Primary completionOct 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dermatitis, ContactStudies 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: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00795951
Sponsor's protocol ID: MEKOS 07 29P1/2/3/401
Status last verified: Dec 2013
First submitted: 20 Nov 2008
Last updated: 6 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents
ClinicalTrials.gov ID: NCT00795951
Acronym / sponsor ID: MEKOS 07 29P1/2/3/401
Conditions: Dermatitis, Contact
Keywords: allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: AllerdermIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Oct 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 21 Nov 2008 (estimated)
Results: Posted 11 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TRUE Test panels 1.1, 2.1, 3.1	Experimental	Biological: T.R.U.E. TestAll subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Children and adolescents 6 to 18 years of age, and in general good health.
Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.

Key exclusion criteria (8 listed)

Topical corticosteroid treatment during the last 7 days on or near the test area.
Systemic treatment with corticosteroids or other immunosuppressive during the last 7 days.
Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
Acute dermatitis outbreak or dermatitis on or near the test area on the back.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T.R.U.E. TestAlso: NA no other names48 hour application of 28 allergens and negative control	Biological	TRUE Test panels 1.1, 2.1, 3.1

Primary outcome

Positive Reactions: Nickel Sulfate
Time frame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Positive Reactions: Neomycin Sulfate
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Positive Reactions: Wool Alcohol
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Potassium Dichromate
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Caine Mix
Time frame: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Fragrance Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Colophony
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Paraben Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Negative Control
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4.
Positive Reactions: Balsam of Peru
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Ethylenediamine Dihydrochloride
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Cobalt Dichloride
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: P-tert Butylphenol Formadehyde Resin
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Epoxy Resin
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Carba Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Black Rubber Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Cl+Me-Isothiazolinone
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Quaternium-15
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Mercaptobenzothiazole
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: p-Phenylenediamine
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Formaldehyde
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Mercapto Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Thimerosal
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Thiuram Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Diazolidinyl Urea
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Imidazolidinyl Urea
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Budesonide
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Tixocortol-21-pivalate
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Quinoline Mix
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Number of subjects with positive reactions recorded at visit 3 and/or visit 4

61 secondary outcomes

Late Reactions: Nickel Sulfate
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Neomycin Sulfate
Time frame: Visit 4: 7 days after patch application
Late Reactions: Wool Alcohol
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Potassium Dichromate
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Caine Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Fragrance Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Colophony
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Paraben Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Negative Control
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Balsam of Peru
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Ethylenediamine Dihydrochloride
Time frame: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
Late Reactions: Cobalt Dichloride
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: P-tert Butylphenol Formadehyde Resin
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Epoxy Resin
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Carba Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Black Rubber Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Cl+Me-Isothiazolinone
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Quaternium-15
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Mercaptobenzothiazole
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: p-Phenylenediamine
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Formaldehyde
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Mercapto Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Thimerosal
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Thiuram Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Diazolidinyl Urea
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Imidazolidinyl Urea
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Budesonide
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Tixocortol-21-pivalate
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Late Reactions: Quinoline Mix
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Persistent Reactions: Nickel Sulfate
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Neomycin Sulfate
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Wool Alcohol
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Potassium Dichromate
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Caine Mix
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Fragrance Mix
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Colophony
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Paraben Mix
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Negative Control
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Balsam of Peru
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Persistent Reactions: Ethylenediamine Dihydrochloride
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Results and safety

Results posted to the registry on 11 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	102	100

Primary outcome: Positive Reactions: Nickel Sulfate

Time frame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application. Number. Unit: participants

Measure	All Subjects n = 100
Value	30

Population analysed: Number of participants analyzed includes all subjects who completed the study.

Primary outcome: Positive Reactions: Neomycin Sulfate

Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application. Number. Unit: participants

Measure	All Subjects n = 100
Value	8

Population analysed: Number of participants analyzed includes all subjects who completed the study.

Primary outcome: Positive Reactions: Wool Alcohol

Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application. Number. Unit: participants

Measure	All Subjects n = 100
Value	16

Population analysed: Number of participants analyzed includes all subjects who completed the study.

Primary outcome: Positive Reactions: Potassium Dichromate

Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application. Number. Unit: participants

Measure	All Subjects n = 100
Value	9

Population analysed: Number of participants analyzed includes all subjects who completed the study.

61 secondary outcomes are reported in the full results.

Adverse events

Time frame: The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety	0 of 102 (0%)	42 of 102 (41.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Lawrence Eichenfield, MD principal investigator

UCSD School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing T.R.U.E. Test in people with Dermatitis, Contact, run by Allerderm 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 4 inclusion and 8 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 6 Aug 2020. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Positive Reactions: Nickel Sulfate (time frame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00795951.

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 6 Aug 2020.