Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

NCT01518348 | Withdrawn Phase 3

• 1 other identifier: Mekos 107P3.2 401
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.

Conditions

Contact Dermatitis

Keywords

Patch Test; Contact Dermatitis; Allergy; Children; PREA

Outcome Measures

Primary Outcomes (1)

• Change in Frequency and characterization of positive reactions per allergen.

  72 hours, 96 hours, 1 week, 21 Days

Secondary Outcomes (1)

• Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

  72 hours, 96 hours, 1 week, 21 days

Study Arms (1)

Patch Test

EXPERIMENTAL

Biological: Patch Test

Interventions

Patch Test BIOLOGICAL

Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone

Also known as: T.R.U.E. TEST

Patch Test

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Informed consent must be signed and understood by subject. If under age, 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 (2)

Anschutz Health and Wellness Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact; Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Cory Dunnick, MD

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

  PRINCIPAL INVESTIGATOR

• Joseph Fowler, MD

  Dermatology Specialists, Louisville, KY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: January 26, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (2)