Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Positive Reactions: Neomycin Sulfate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Positive Reactions: Neomycin Sulfate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Late Reactions: Wool Alcohol(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Potassium Dichromate(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Tixocortol-21-pivalate(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Epoxy Resin(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Carba Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Black Rubber Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- 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)
- 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)
- Late Reactions: Neomycin Sulfate(Visit 4: 7 days after patch application)
- Late Reactions: Colophony(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Cl+Me-Isothiazolinone(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Mercapto Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Budesonide(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- 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)
- 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)
- 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)
- 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)
- Late Reactions: Mercaptobenzothiazole(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: p-Phenylenediamine(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Formaldehyde(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Thimerosal(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- 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)
- 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)
- 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)
- 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)
- Late Reactions: Nickel Sulfate(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Caine Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Fragrance Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Quaternium-15(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Thiuram Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Diazolidinyl Urea(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- 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)
- 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)
- 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)
- 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)
- 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)
- Late Reactions: Paraben Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Negative Control(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Balsam of Peru(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Ethylenediamine Dihydrochloride(Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Cobalt Dichloride(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: P-tert Butylphenol Formadehyde Resin(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Imidazolidinyl Urea(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- Late Reactions: Quinoline Mix(Visit 4: 7 days after patch application or Visit 5: 21 days after patch application)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Subject Reported Itching and Burning(Visit 2 (day 1) following to panel removal.)
- 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)
- 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)
- Panel Adhesion Evaluation(Visit 2 (day 1) prior to panel removal.)
- Panel Irritation(Visit 2 (day 1) following to panel removal.)