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

NCT01797562 | Completed Results

• 1 other identifier: SP 12 7NEW 401
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 4

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.

Conditions

Allergic Contact Dermatitis

Keywords

Contact dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• 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

  Investigator Determination of Positive Reaction: 21 days post application

Secondary Outcomes (1)

• Number of Participants With Late or Persistent Positive Patch Test Reactions

  Day 7-21

Study Arms (1)

Positive Response Rates: 7 new and 4 reformulated allergens

EXPERIMENTAL

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

Interventions

Panels 1.3, 2.2 and 3.2 experimental allergens DIAGNOSTIC_TEST

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.

Positive Response Rates: 7 new and 4 reformulated allergens

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Symptoms and history potentially consistent with allergic contact dermatitis
• Children and adolescents 6-17 years of age, in general good health
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allerderm: lead

Study Sites (4)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Anschutz Health and Wellness Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Dermatitis, Contact; Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Kathryn Shannon
• Organization: Allerderm(dba) SmartPractice

kshannon@smarthealth.com

602 225 0595

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: December 10, 2012
• Primary Completion: September 8, 2015
• Study Completion: September 8, 2015
• Last Updated: August 21, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-04

Locations

US (4)