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

Phase 4

Completed

Conditions: Dermatitis, Contact

Interventions: Biological: T.R.U.E. Test

Registration Number: NCT00795951

Lead Sponsor: Allerderm

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRUE Test panels 1.1, 2.1, 3.1	T.R.U.E. Test	All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.

Primary Outcome Measures

Name	Time	Method
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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

Name	Time	Method
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: 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: 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.
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: 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.
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: 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: 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: 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: 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.
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: 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.
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: 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: 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.
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: 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: 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.
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: 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: 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: 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.
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: 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: 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: 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.
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
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)
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: 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)