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

Allerderm102 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

102

Conditions

Dermatitis, Contact

Interventions

T.R.U.E. TestBIOLOGICAL

48 hour application of 28 allergens and negative control

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rady Children's Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

Positive Reactions: Nickel Sulfate

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

Positive Reactions: Neomycin Sulfate

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

Positive Reactions: Wool Alcohol

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

Positive Reactions: Potassium Dichromate

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

Positive Reactions: Caine Mix

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

Positive Reactions: Fragrance Mix

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

Positive Reactions: Colophony

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Late Reactions: Nickel Sulfate

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Neomycin Sulfate

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application

Late Reactions: Wool Alcohol

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Potassium Dichromate

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Caine Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Fragrance Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Colophony

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Paraben Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Negative Control

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Balsam of Peru

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Ethylenediamine Dihydrochloride

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application

Late Reactions: Cobalt Dichloride

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: P-tert Butylphenol Formadehyde Resin

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Epoxy Resin

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Carba Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Black Rubber Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Cl+Me-Isothiazolinone

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Quaternium-15

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Mercaptobenzothiazole

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: p-Phenylenediamine

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Formaldehyde

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Mercapto Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Thimerosal

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Thiuram Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Diazolidinyl Urea

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Imidazolidinyl Urea

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Budesonide

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Tixocortol-21-pivalate

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Late Reactions: Quinoline Mix

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Persistent Reactions: Nickel Sulfate