Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Sponsor
Allerderm (Industry)
Overall Status
Completed
CT.gov ID
NCT00795951
Collaborator
(none)
102
1
1
12
8.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents
Study Start Date
:
Nov 1, 2008
Actual Primary Completion Date
:
Oct 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TRUE Test panels 1.1, 2.1, 3.1 All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control. |
Biological: T.R.U.E. Test
48 hour application of 28 allergens and negative control
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Positive Reactions: Nickel Sulfate [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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
Secondary Outcome Measures
- Late Reactions: Nickel Sulfate [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
- Late Reactions: Colophony [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
- Late Reactions: Mercaptobenzothiazole [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
- Late Reactions: Formaldehyde [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
- Late Reactions: Thimerosal [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
- Late Reactions: Budesonide [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [Visit 4: 7 days after patch application or Visit 5: 21 days after patch application]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [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]
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 [Visit 2 (day 1) prior to panel removal.]
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 [Visit 2 (day 1) following to panel removal.]
Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
- Subject Reported Itching and Burning [Visit 2 (day 1) following to panel removal.]
Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rady Children's Hospital | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- Allerderm
Investigators
- Principal Investigator: Lawrence Eichenfield, MD, UCSD School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Allerderm
ClinicalTrials.gov Identifier:
NCT00795951
Other Study ID Numbers:
- MEKOS 07 29P1/2/3/401
First Posted:
Nov 21, 2008
Last Update Posted:
Aug 6, 2020
Last Verified:
Dec 1, 2013
Keywords provided by Allerderm
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited) |
|---|---|
| Pre-assignment Detail | No significant events or approaches |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test Allergen Panel evaluations |
| Period Title: Overall Study | |
| STARTED | 102 |
| COMPLETED | 100 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1 |
| Overall Participants | 102 |
| Age (Count of Participants) | |
| <=18 years |
102
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
11.6
(3.61)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
53
52%
|
| Male |
49
48%
|
| Region of Enrollment (participants) [Number] | |
| United States |
102
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
30
29.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
8
7.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
16
15.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
9
8.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | Diagnostic Performance |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
13
12.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
9
8.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
11
10.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
5
4.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
13
12.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
17
16.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
7
6.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
7
6.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
7
6.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
5
4.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
8
7.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | Diagnostic Performance |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
16
15.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
5
4.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
6
5.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
3
2.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
5
4.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
4
3.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
5
4.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
6
5.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
3
2.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
2
2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
3
2.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed includes all subjects who completed the study. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Number [participants] |
1
1%
|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who completed the study are included in the analysis. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| Excellent |
71
69.6%
|
| Good |
19
18.6%
|
| Fair |
8
7.8%
|
| Poor |
2
2%
|
| Fell off |
0
0%
|
| Excellent |
72
70.6%
|
| Good |
19
18.6%
|
| Fair |
9
8.8%
|
| Poor |
0
0%
|
| Fell off |
0
0%
|
| Excellent |
82
80.4%
|
| Good |
14
13.7%
|
| Fair |
3
2.9%
|
| Poor |
1
1%
|
| Fell off |
0
0%
|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who completed the study are included in the analysis. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| None |
38
37.3%
|
| Weak |
43
42.2%
|
| Moderate |
16
15.7%
|
| Strong |
3
2.9%
|
| None |
37
36.3%
|
| Weak |
43
42.2%
|
| Moderate |
16
15.7%
|
| Strong |
4
3.9%
|
| None |
40
39.2%
|
| Weak |
40
39.2%
|
| Moderate |
18
17.6%
|
| Strong |
2
2%
|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who completed the study are included in the analysis. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | T.R.U.E. Test allergen panel evaluations |
| Measure Participants | 100 |
| None |
33
32.4%
|
| Weak |
34
33.3%
|
| Moderate |
12
11.8%
|
| Strong |
21
20.6%
|
| None |
44
43.1%
|
| Weak |
32
31.4%
|
| Moderate |
15
14.7%
|
| Strong |
9
8.8%
|
| None |
60
58.8%
|
| Weak |
23
22.5%
|
| Moderate |
5
4.9%
|
| Strong |
12
11.8%
|
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. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Safety | |
| Arm/Group Description | Adverse Events | |
All Cause Mortality |
||
| Safety | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Safety | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Safety | ||
| Affected / at Risk (%) | # Events | |
| Total | 42/102 (41.2%) | |
| Infections and infestations | ||
| Fever | 2/102 (2%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Worsening of rash | 26/102 (25.5%) | 34 |
| Flare-up of rash | 2/102 (2%) | 2 |
| Boil on forehead | 1/102 (1%) | 1 |
| Rash | 2/102 (2%) | 2 |
| Reaction around panel 2.1 | 1/102 (1%) | 1 |
| Edema, vesiculation pain on hands | 1/102 (1%) | 1 |
| Worsening of underlying condition | 1/102 (1%) | 1 |
| Slight worsening of spot on leg | 1/102 (1%) | 1 |
| Lesion on right thumb | 1/102 (1%) | 1 |
| Worsening of dermatitis | 1/102 (1%) | 1 |
| Reaction on place of panel | 1/102 (1%) | 1 |
| Vascular disorders | ||
| Headache | 2/102 (2%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | SE Jacob, MD and L Eichenfield, MD |
|---|---|
| Organization | Rady Children's Hospital, San Diego, CA |
| Phone | 858-576-1700 ext 4825 |
| leichenfield@rchsd.org |
Responsible Party:
Allerderm
ClinicalTrials.gov Identifier:
NCT00795951
Other Study ID Numbers:
- MEKOS 07 29P1/2/3/401
First Posted:
Nov 21, 2008
Last Update Posted:
Aug 6, 2020
Last Verified:
Dec 1, 2013