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
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Dermatitis, Contact
Intervention: Biological: T.R.U.E. Test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events or approaches

Reporting Groups
  Description
Diagnostic Performance: Nickel Sulfate Number of subjects with reactions recorded at visit 3 or 4

Participant Flow:   Overall Study
    Diagnostic Performance: Nickel Sulfate  
STARTED     102  
COMPLETED     100  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Arm Study All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1

Baseline Measures
    Single Arm Study  
Number of Participants  
[units: participants]
  102  
Age  
[units: participants]
 
<=18 years     102  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.6  ± 3.61  
Gender  
[units: participants]
 
Female     53  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     102  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Diagnostic Performance: Nickel Sulfate   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

2.  Primary:   Diagnostic Performance: Neomycin Sulfate   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

3.  Primary:   Diagnostic Performance: Wool Alcohol   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

4.  Primary:   Diagnostic Performance: Potassium Dichromate   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

5.  Primary:   Diagnostic Performance: Caine Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

6.  Primary:   Diagnostic Performance: Fragrance Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

7.  Primary:   Diagnostic Performance: Colophony   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

8.  Primary:   Diagnostic Performance: Paraben Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

9.  Primary:   Diagnostic Performance: Negative Control   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

10.  Primary:   Diagnostic Performance: Balsam of Peru   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

11.  Primary:   Diagnostic Performance: Ethylenediamine Dihydrochloride   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

12.  Primary:   Diagnostic Performance: Cobalt Dichloride   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

13.  Primary:   Diagnostic Performance: P-tert Butylphenol Formadehyde Resin   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

14.  Primary:   Diagnostic Performance: Epoxy Resin   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

15.  Primary:   Diagnostic Performance: Carba Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

16.  Primary:   Diagnostic Performance: Black Rubber Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

17.  Primary:   Diagnostic Performance: Cl+Me-Isothiazolinone   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

18.  Primary:   Diagnostic Performance: Quaternium-15   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

19.  Primary:   Diagnostic Performance: Mercaptobenzothiazole   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

20.  Primary:   Diagnostic Performance: p-Phenylenediamine   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

21.  Primary:   Diagnostic Performance: Formaldehyde   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

22.  Primary:   Diagnostic Performance: Mercapto Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

23.  Primary:   Diagnostic Performance: Thimerosal   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

24.  Primary:   Diagnostic Performance: Thiuram Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

25.  Primary:   Diagnostic Performance: Diazolidinyl Urea   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

26.  Primary:   Diagnostic Performance: Imidazolidinyl Urea   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

27.  Primary:   Diagnostic Performance: Budesonide   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

28.  Primary:   Diagnostic Performance: Tixocortol-21-pivalate   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

29.  Primary:   Diagnostic Performance: Quinoline Mix   [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]

30.  Secondary:   Late Reactions   [ Time Frame: 7-10 days after patch application ]

31.  Secondary:   Persistent Reactions   [ Time Frame: appear 2-4 days after patch application and last through 7-14 days after application ]

32.  Secondary:   Irritation   [ Time Frame: Visit 2: 48 hours after patch application ]

33.  Secondary:   Adhesion   [ Time Frame: Day 2: 48 hours after application ]

34.  Secondary:   Itching/Burning   [ Time Frame: Day 2: 48 hours after patch application ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: SE Jacob, MD and L Eichenfield, MD
Organization: Rady Children’s Hospital, San Diego, CA
phone: 858-576-1700 ext 4825
e-mail: leichenfield@rchsd.org


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