Back to resultsClinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Primary Purpose
Dermatitis, Contact
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
T.R.U.E. Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Dermatitis, Contact focused on measuring allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST
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.
Sites / Locations
- Rady Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRUE Test panels 1.1, 2.1, 3.1
Arm Description
All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.
Outcomes
Primary Outcome Measures
Positive Reactions: Nickel Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Positive Reactions: Neomycin Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Positive Reactions: Wool Alcohol
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Potassium Dichromate
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Caine Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Fragrance Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Colophony
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Paraben Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Negative Control
Number of subjects with positive reactions recorded at visit 3 and/or visit 4.
Positive Reactions: Balsam of Peru
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Ethylenediamine Dihydrochloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Cobalt Dichloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Epoxy Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Carba Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Black Rubber Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Cl+Me-Isothiazolinone
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Quaternium-15
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Mercaptobenzothiazole
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: p-Phenylenediamine
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Formaldehyde
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Mercapto Mix
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Thimerosal
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Thiuram Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Diazolidinyl Urea
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Imidazolidinyl Urea
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Budesonide
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Positive Reactions: Tixocortol-21-pivalate
Number of subjects with positive reactions at visit 3 and/or visit 4
Positive Reactions: Quinoline Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Late Reactions: Colophony
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Late Reactions: Mercaptobenzothiazole
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
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.
Late Reactions: Formaldehyde
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
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.
Late Reactions: Thimerosal
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
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.
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.
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.
Late Reactions: Budesonide
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Panel Irritation
Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Subject Reported Itching and Burning
Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795951
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Contact
Keywords
allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRUE Test panels 1.1, 2.1, 3.1
Arm Type
Experimental
Arm Description
All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.
Intervention Type
Biological
Intervention Name(s)
T.R.U.E. Test
Other Intervention Name(s)
NA no other names
Intervention Description
48 hour application of 28 allergens and negative control
Primary Outcome Measure Information:
Title
Positive Reactions: Nickel Sulfate
Description
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Neomycin Sulfate
Description
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Wool Alcohol
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Potassium Dichromate
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Caine Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
Title
Positive Reactions: Fragrance Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Colophony
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Paraben Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Negative Control
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4.
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Balsam of Peru
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Ethylenediamine Dihydrochloride
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
Title
Positive Reactions: Cobalt Dichloride
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: P-tert Butylphenol Formadehyde Resin
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Epoxy Resin
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Carba Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Black Rubber Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Cl+Me-Isothiazolinone
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Quaternium-15
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Mercaptobenzothiazole
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: p-Phenylenediamine
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Formaldehyde
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Mercapto Mix
Description
Number of subjects with positive reactions at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Thimerosal
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Thiuram Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Diazolidinyl Urea
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Imidazolidinyl Urea
Description
Number of subjects with positive reactions at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Budesonide
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Tixocortol-21-pivalate
Description
Number of subjects with positive reactions at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Title
Positive Reactions: Quinoline Mix
Description
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time Frame
Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Secondary Outcome Measure Information:
Title
Late Reactions: Nickel Sulfate
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Neomycin Sulfate
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application
Title
Late Reactions: Wool Alcohol
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Potassium Dichromate
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Caine Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Fragrance Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Colophony
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Paraben Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Negative Control
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Balsam of Peru
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Ethylenediamine Dihydrochloride
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Cobalt Dichloride
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: P-tert Butylphenol Formadehyde Resin
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Epoxy Resin
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Carba Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Black Rubber Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Cl+Me-Isothiazolinone
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Quaternium-15
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Mercaptobenzothiazole
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: p-Phenylenediamine
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Formaldehyde
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Mercapto Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Thimerosal
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Thiuram Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Diazolidinyl Urea
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Imidazolidinyl Urea
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Budesonide
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Tixocortol-21-pivalate
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Late Reactions: Quinoline Mix
Description
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time Frame
Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Title
Persistent Reactions: Nickel Sulfate
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Neomycin Sulfate
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Wool Alcohol
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Potassium Dichromate
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Caine Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Fragrance Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Colophony
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Paraben Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Negative Control
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Balsam of Peru
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Ethylenediamine Dihydrochloride
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Cobalt Dichloride
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: P-tert Butylphenol Formadehyde Resin
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Epoxy Resin
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Carba Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Black Rubber Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Cl+Me-Isothiazolinone
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Quaternium-15
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: p-Phenylenediamine
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Formaldehyde
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Mercapto Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Thimerosal
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Thiuram Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Diazolidinyl Urea
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Imidazolidinyl Urea
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Budesonide
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Tixocortol-21-pivalate
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Quinoline Mix
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Persistent Reactions: Mercaptobenzothiazole
Description
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
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
Title
Panel Adhesion Evaluation
Description
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.
Time Frame
Visit 2 (day 1) prior to panel removal.
Title
Panel Irritation
Description
Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Time Frame
Visit 2 (day 1) following to panel removal.
Title
Subject Reported Itching and Burning
Description
Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Time Frame
Visit 2 (day 1) following to panel removal.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Eichenfield, MD
Organizational Affiliation
UCSD School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
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