Clinical trial NCT00795951: Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Contact
Keywords: allergic
contact dermatitis
contact allergy
Type IV
Children
TRUE TEST
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Positive Reactions: Nickel Sulfate
timeFrame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Neomycin Sulfate
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Wool Alcohol
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Potassium Dichromate
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Caine Mix
timeFrame: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
measure: Positive Reactions: Fragrance Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Colophony
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Paraben Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Negative Control
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Balsam of Peru
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Ethylenediamine Dihydrochloride
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
measure: Positive Reactions: Cobalt Dichloride
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: P-tert Butylphenol Formadehyde Resin
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Epoxy Resin
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Carba Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Black Rubber Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Cl+Me-Isothiazolinone
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Quaternium-15
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Mercaptobenzothiazole
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: p-Phenylenediamine
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Formaldehyde
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Mercapto Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Thimerosal
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Thiuram Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Diazolidinyl Urea
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Imidazolidinyl Urea
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Budesonide
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Tixocortol-21-pivalate
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
measure: Positive Reactions: Quinoline Mix
timeFrame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Secondary outcomes:
measure: Late Reactions: Nickel Sulfate
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Neomycin Sulfate
timeFrame: Visit 4: 7 days after patch application
measure: Late Reactions: Wool Alcohol
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Potassium Dichromate
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Caine Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Fragrance Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Colophony
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Paraben Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Negative Control
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Balsam of Peru
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Ethylenediamine Dihydrochloride
timeFrame: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Cobalt Dichloride
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: P-tert Butylphenol Formadehyde Resin
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Epoxy Resin
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Carba Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Black Rubber Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Cl+Me-Isothiazolinone
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Quaternium-15
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Mercaptobenzothiazole
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: p-Phenylenediamine
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Formaldehyde
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Mercapto Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Thimerosal
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Thiuram Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Diazolidinyl Urea
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Imidazolidinyl Urea
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Budesonide
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Tixocortol-21-pivalate
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Late Reactions: Quinoline Mix
timeFrame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
measure: Persistent Reactions: Nickel Sulfate
timeFrame: 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
measure: Persistent Reactions: Neomycin Sulfate
timeFrame: 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
measure: Persistent Reactions: Wool Alcohol
timeFrame: 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
measure: Persistent Reactions: Potassium Dichromate
timeFrame: 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
measure: Persistent Reactions: Caine Mix
timeFrame: 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
measure: Persistent Reactions: Fragrance Mix
timeFrame: 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
measure: Persistent Reactions: Colophony
timeFrame: 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
measure: Persistent Reactions: Paraben Mix
timeFrame: 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
measure: Persistent Reactions: Negative Control
timeFrame: 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
measure: Persistent Reactions: Balsam of Peru
timeFrame: 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
measure: Persistent Reactions: Ethylenediamine Dihydrochloride
timeFrame: 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
measure: Persistent Reactions: Cobalt Dichloride
timeFrame: 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
measure: Persistent Reactions: P-tert Butylphenol Formadehyde Resin
timeFrame: 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
measure: Persistent Reactions: Epoxy Resin
timeFrame: 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
measure: Persistent Reactions: Carba Mix
timeFrame: 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
measure: Persistent Reactions: Black Rubber Mix
timeFrame: 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
measure: Persistent Reactions: Cl+Me-Isothiazolinone
timeFrame: 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
measure: Persistent Reactions: Quaternium-15
timeFrame: 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
measure: Persistent Reactions: p-Phenylenediamine
timeFrame: 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
measure: Persistent Reactions: Formaldehyde
timeFrame: 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
measure: Persistent Reactions: Mercapto Mix
timeFrame: 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
measure: Persistent Reactions: Thimerosal
timeFrame: 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
measure: Persistent Reactions: Thiuram Mix
timeFrame: 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
measure: Persistent Reactions: Diazolidinyl Urea
timeFrame: 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
measure: Persistent Reactions: Imidazolidinyl Urea
timeFrame: 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
measure: Persistent Reactions: Budesonide
timeFrame: 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
measure: Persistent Reactions: Tixocortol-21-pivalate
timeFrame: 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
measure: Persistent Reactions: Quinoline Mix
timeFrame: 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
measure: Persistent Reactions: Mercaptobenzothiazole
timeFrame: 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
measure: Panel Adhesion Evaluation
timeFrame: Visit 2 (day 1) prior to panel removal.
measure: Panel Irritation
timeFrame: Visit 2 (day 1) following to panel removal.
measure: Subject Reported Itching and Burning
timeFrame: Visit 2 (day 1) following to panel removal.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: UCSD School of Medicine
name: Lawrence Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
References: