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Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Allerderm.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797562
First Posted: February 22, 2013
Last Update Posted: September 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allerderm
  Purpose
To evaluate the performance and safety of seven T.R.U.E. Test Panel allergens in subjects 6-17 years of age with suspected contact dermatitis.

Condition Intervention Phase
Allergic Contact Dermatitis Drug: T.R.U.E. Test Panel 3.2 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Frequency and characterization of positive reactions per allergen. [ Time Frame: Day 21 ]

Secondary Outcome Measures:
  • Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events. [ Time Frame: Day 21 ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T.R.U.E. Test Panel 3.2
T.R.U.E. Test Panel allergens; Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol
Drug: T.R.U.E. Test Panel 3.2
Surgical tape containing 12 polyester allergen patches.
Other Names:
  • Gold sodium thiosulfate
  • Hydrocortisone-17-butyrate
  • Bacitracin
  • Parthenolide
  • Methyldibromoglutaronitrile
  • Disperse blue 106
  • Bronopol

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms and history potentially consistent with allergic contact dermatitis
  • Children and adolescents 6-17 years of age, 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797562


Contacts
Contact: Kim Sullivan 602-225-0595

Locations
United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Ann Funk, RN    858-576-1700 ext 4295      
Principal Investigator: Lawrence Eichenfield, MD         
United States, Colorado
Anschutz Health and Wellness Center, University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Teresa Derian, RN    303-724-9155      
Principal Investigator: Cory Dunnick, MD         
United States, Kentucky
Dermatology Specialists Recruiting
Louisville, Kentucky, United States, 40202
Contact: Maureen Beyel, RN    502-582-7546      
Principal Investigator: Joseph Fowler, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kristin Morton    503-494-6442      
Principal Investigator: Patricia Norris, MD         
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: Cory Dunnick, MD Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
Principal Investigator: Joseph Fowler, MD Dermatology Specialists, Louisville, KY
Principal Investigator: Lawrence Eichenfield, MD Rady Children's Hospital, San Diego
Principal Investigator: Patricia Norris, MD Oregon Health and Science University
  More Information

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT01797562     History of Changes
Other Study ID Numbers: SP 12 7NEW 401
First Submitted: February 20, 2013
First Posted: February 22, 2013
Last Update Posted: September 23, 2014
Last Verified: December 2013

Keywords provided by Allerderm:
Contact dermatitis
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Parthenolide
Hydrocortisone
Sodium thiosulfate
Bacitracin
Bronopol
Hydrocortisone-17-butyrate
Gold Sodium Thiosulfate
Anti-Inflammatory Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents
Anti-Infective Agents, Local