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Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Primary Purpose

Allergic Contact Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Panels 1.3, 2.2 and 3.2 experimental allergens
Sponsored by
Allerderm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Contact Dermatitis focused on measuring Contact dermatitis, Eczema

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms and history potentially consistent with allergic contact dermatitis
  • Children and adolescents 6-17 years of age, 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 immunosuppressives 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

Sites / Locations

  • Rady Children's Hospital
  • Anschutz Health and Wellness Center, University of Colorado
  • Dermatology Specialists
  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive Response Rates: 7 new and 4 reformulated allergens

Arm Description

Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated

Outcomes

Primary Outcome Measures

Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction

Secondary Outcome Measures

Number of Participants With Late or Persistent Positive Patch Test Reactions
Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.

Full Information

First Posted
February 20, 2013
Last Updated
August 12, 2020
Sponsor
Allerderm
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1. Study Identification

Unique Protocol Identification Number
NCT01797562
Brief Title
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Official Title
Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2012 (Actual)
Primary Completion Date
September 8, 2015 (Actual)
Study Completion Date
September 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Detailed Description
The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis
Keywords
Contact dermatitis, Eczema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Response Rates: 7 new and 4 reformulated allergens
Arm Type
Experimental
Arm Description
Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated
Intervention Type
Diagnostic Test
Intervention Name(s)
Panels 1.3, 2.2 and 3.2 experimental allergens
Intervention Description
Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
Primary Outcome Measure Information:
Title
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Description
Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction
Time Frame
Investigator Determination of Positive Reaction: 21 days post application
Secondary Outcome Measure Information:
Title
Number of Participants With Late or Persistent Positive Patch Test Reactions
Description
Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.
Time Frame
Day 7-21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms and history potentially consistent with allergic contact dermatitis Children and adolescents 6-17 years of age, 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 immunosuppressives 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cory Dunnick, MD
Organizational Affiliation
Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Fowler, MD
Organizational Affiliation
Dermatology Specialists, Louisville, KY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Eichenfield, MD
Organizational Affiliation
Rady Children's Hospital, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Norris, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Anschutz Health and Wellness Center, University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

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