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

NCT ID: NCT01797562

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-10
• Study Completion Date: 2015-09-08

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.

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Panels 1.3, 2.2 and 3.2 experimental allergens

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cory Dunnick, MD

Role: PRINCIPAL_INVESTIGATOR

Anschutz Health and Wellness Center, University of Colorado, Aurora, CO

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists, Louisville, KY

Lawrence Eichenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Children's Hospital, San Diego

Patricia Norris, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Rady Children's Hospital

San Diego, California, United States

Anschutz Health and Wellness Center, University of Colorado

Aurora, Colorado, United States

Dermatology Specialists

Louisville, Kentucky, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

SP 12 7NEW 401

Identifier Type: -

Identifier Source: org_study_id