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

Dermatitis, Contact Clinical Trial

Official title:

Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795951
• Other study ID #: MEKOS 07 29P1/2/3/401
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2013
• Source: Allerderm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact

Intervention

Biological:
• T.R.U.E. Test
48 hour application of 28 allergens and negative control

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Allerderm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Reactions: Nickel Sulfate	Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4	Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Neomycin Sulfate	Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Wool Alcohol	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Potassium Dichromate	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Caine Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
Primary	Positive Reactions: Fragrance Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Colophony	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Paraben Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Negative Control	Number of subjects with positive reactions recorded at visit 3 and/or visit 4.	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Balsam of Peru	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Ethylenediamine Dihydrochloride	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
Primary	Positive Reactions: Cobalt Dichloride	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: P-tert Butylphenol Formadehyde Resin	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Epoxy Resin	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Carba Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Black Rubber Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Cl+Me-Isothiazolinone	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Quaternium-15	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Mercaptobenzothiazole	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: p-Phenylenediamine	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Formaldehyde	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Mercapto Mix	Number of subjects with positive reactions at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Thimerosal	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Thiuram Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Diazolidinyl Urea	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Imidazolidinyl Urea	Number of subjects with positive reactions at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Budesonide	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Tixocortol-21-pivalate	Number of subjects with positive reactions at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Primary	Positive Reactions: Quinoline Mix	Number of subjects with positive reactions recorded at visit 3 and/or visit 4	Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Late Reactions: Colophony	Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Late Reactions: Mercaptobenzothiazole	Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Late Reactions: Formaldehyde	Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Late Reactions: Thimerosal	Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Late Reactions: Budesonide	Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	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.	Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Secondary	Persistent Reactions: Nickel Sulfate	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Neomycin Sulfate	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Wool Alcohol	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Potassium Dichromate	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Caine Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Fragrance Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Colophony	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Paraben Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Negative Control	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Balsam of Peru	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Ethylenediamine Dihydrochloride	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Cobalt Dichloride	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: P-tert Butylphenol Formadehyde Resin	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Epoxy Resin	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Carba Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Black Rubber Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Cl+Me-Isothiazolinone	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Quaternium-15	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: p-Phenylenediamine	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Formaldehyde	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Mercapto Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Thimerosal	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Thiuram Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Diazolidinyl Urea	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Imidazolidinyl Urea	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Budesonide	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Tixocortol-21-pivalate	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Quinoline Mix	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Persistent Reactions: Mercaptobenzothiazole	Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.	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
Secondary	Panel Adhesion Evaluation	Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.	Visit 2 (day 1) prior to panel removal.
Secondary	Panel Irritation	Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)	Visit 2 (day 1) following to panel removal.
Secondary	Subject Reported Itching and Burning	Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)	Visit 2 (day 1) following to panel removal.