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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT00795951
First received: November 20, 2008
Last updated: December 19, 2013
Last verified: December 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Diagnostic Performance: Nickel Sulfate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Neomycin Sulfate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Wool Alcohol [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Potassium Dichromate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Caine Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Fragrance Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Colophony [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Paraben Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Negative Control [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4.

  • Diagnostic Performance: Balsam of Peru [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Ethylenediamine Dihydrochloride [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Cobalt Dichloride [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: P-tert Butylphenol Formadehyde Resin [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Epoxy Resin [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Carba Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Black Rubber Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Cl+Me-Isothiazolinone [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Quaternium-15 [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Mercaptobenzothiazole [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: p-Phenylenediamine [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Formaldehyde [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Mercapto Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions at visit 3 or visit 4

  • Diagnostic Performance: Thimerosal [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Thiuram Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Diazolidinyl Urea [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Imidazolidinyl Urea [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions at visit 3 or visit 4

  • Diagnostic Performance: Budesonide [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4

  • Diagnostic Performance: Tixocortol-21-pivalate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions at visit 3 or visit 4

  • Diagnostic Performance: Quinoline Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4


Secondary Outcome Measures:
  • Late Reactions [ Time Frame: 7-10 days after patch application ] [ Designated as safety issue: No ]
    Number of subjects who presented with late reactions

  • Persistent Reactions [ Time Frame: appear 2-4 days after patch application and last through 7-14 days after application ] [ Designated as safety issue: No ]
    Number of subjects who presented with persistent reactions

  • Irritation [ Time Frame: Visit 2: 48 hours after patch application ] [ Designated as safety issue: Yes ]
    Number of subjects who presented with irritation at patch removal

  • Adhesion [ Time Frame: Day 2: 48 hours after application ] [ Designated as safety issue: No ]
    Number of subjects who presented with poor adhesion at patch removal

  • Itching/Burning [ Time Frame: Day 2: 48 hours after patch application ] [ Designated as safety issue: Yes ]
    Number of subjects who presented with itching/burning at patch removal


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
Experimental: TRUE Test panels 1.1, 2,1, 3,1
All subjects were patched with TRUE Test panels 1.1, 2,1 and 3.1
Biological: T.R.U.E. Test
48 hour application of 28 allergens and negative control
Other Name: NA no other names

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Allerderm
ClinicalTrials.gov Identifier: NCT00795951     History of Changes
Other Study ID Numbers: MEKOS 07 29P1/2/3/401
Study First Received: November 20, 2008
Results First Received: February 19, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014