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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01797562
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : August 12, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Allerderm

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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Actual Study Start Date : December 10, 2012
Actual Primary Completion Date : September 8, 2015
Actual Study Completion Date : September 8, 2015

Arm Intervention/treatment
Experimental: Positive Response Rates: 7 new and 4 reformulated allergens
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
Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens
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 Measures :
  1. Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores [ Time Frame: Investigator Determination of Positive Reaction: 21 days post application ]
    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 :
  1. Number of Participants With Late or Persistent Positive Patch Test Reactions [ Time Frame: Day 7-21 ]

    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.




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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797562


Locations
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United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Allerderm
Investigators
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Principal Investigator: Cory Dunnick, MD Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
Principal Investigator: Joseph Fowler, MD Dermatology Specialists, Louisville, KY
Principal Investigator: Lawrence Eichenfield, MD Rady Children's Hospital, San Diego
Principal Investigator: Patricia Norris, MD Oregon Health and Science University
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Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT01797562    
Other Study ID Numbers: SP 12 7NEW 401
First Posted: February 22, 2013    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: August 21, 2020
Last Verified: April 2020
Keywords provided by Allerderm:
Contact dermatitis
Eczema
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases