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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 (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT00795951
First received: November 20, 2008
Last updated: December 19, 2013
Last verified: December 2013

November 20, 2008
December 19, 2013
November 2008
October 2009   (final data collection date for primary outcome measure)
  • 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
Frequency and characterization of positive reactions per allergen. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00795951 on ClinicalTrials.gov Archive Site
  • 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
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 ]
Not Provided
Not Provided
 
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Dermatitis, Contact
Biological: T.R.U.E. Test
48 hour application of 28 allergens and negative control
Other Name: NA no other names
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
Intervention: Biological: T.R.U.E. Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795951
MEKOS 07 29P1/2/3/401
No
Allerderm
Allerderm
Not Provided
Principal Investigator: Lawrence Eichenfield, MD UCSD School of Medicine
Allerderm
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP