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

This study has been completed.
Sponsor:
Information provided by:
Allerderm
ClinicalTrials.gov Identifier:
NCT00795951
First received: November 20, 2008
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  Purpose

An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents


Condition Intervention Phase
Dermatitis, Contact
 Biological: T.R.U.E. Test
Biological: TRUE TEST Diagnostic Patch Test
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Frequency and characterization of positive reactions per allergen. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diagnostic
Patch Test
 Biological: T.R.U.E. Test
Diagnostic- 48 hour duration, 28 allergens
Other Name: Patch Test
Biological: TRUE TEST Diagnostic Patch Test
Diagnostic- 28 allergens and negative control
Other Name: Patch Test

Detailed Description:

An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents. After consent and enrollment, the timeline is as follows:A. T.R.U.E. TEST panels 1.1, 2.1 ,3.1 will be applied to the skin on the subject's back. All patch test panels will remain at the back until removed at the #2 Clinic Visit that occurs 2 days later. B. Skin reactions to all patch test panel allergens will be evaluated and scored shortly after panel removal.C. Skin reactions will be evaluated and scored again at either 3 or 4 days after #1 Clinic Visit. An additional follow-up visit (#3B Clinic Visit) may occur days after day 0 if needed to verify skin reactions.D. Skin reactions will be evaluated and scored again at the #4 Clinic Visit, which will occur 7 days +/- 2 days after #1 Clinic Visit (day 0). E. A follow up visit will take place approximately 3 weeks (21 + 2 days) after #1 Clinic Visit (day 0) to record any late or persistent reactions, and any adverse events. Investigators may elect to perform this evaluation via telephone if no reactions are present.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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 immunosuppressive 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795951

Locations
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: Lawrence Eichenfield, MD UCSD School of Medicine
  More Information

No publications provided

Responsible Party: Kim M. Sullivan / Regulatory Vice President, Allerderm
ClinicalTrials.gov Identifier: NCT00795951     History of Changes
Other Study ID Numbers: MEKOS 07 29P1/2/3/401
Study First Received: November 20, 2008
Last Updated: May 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Allerderm:
allergic
contact dermatitis
contact allergy
 TypeIV
Children
TRUE TEST

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on May 23, 2013