Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents (PREAII)

This study has been withdrawn prior to enrollment.
(Study has been updated with new protocol number)
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT01518348
First received: March 16, 2011
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.


Condition Intervention Phase
Contact Dermatitis
Biological: Patch Test
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Change in Frequency and characterization of positive reactions per allergen. [ Time Frame: 72 hours, 96 hours, 1 week, 21 Days ] [ 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: 72 hours, 96 hours, 1 week, 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patch Test Biological: Patch Test
Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone
Other Name: T.R.U.E. TEST

Detailed Description:

The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy and fulfill entry criteria.

Visit 1 (Day 0): Informed Consent, Inclusion/Exclusion Criteria Assessment, Medical and Medicine History, Pregnancy Test (for female subjects of child-bearing potential), Panel Placement.Visit 2 (Day 2): Panel Removal, Panel Adhesion and Irritation Assessment, AE and Concomitant Medication Review.Visit 3 (Day 3- approximately 72 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 4 (Day 4 approximately 96 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 5 (Day 7±1): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit 6 (Day 21±2): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit performed via phone call, unless investigator determines that subject should be seen in clinic.

Primary Endpoint: Frequency and characterization of positive reactions per allergen. Secondary Endpoint: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

  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 under age, 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
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: NCT01518348

Locations
United States, Colorado
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: Cory Dunnick, MD Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado
Principal Investigator: Joseph Fowler, MD Dermatology Specialists, Louisville, KY
  More Information

No publications provided

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT01518348     History of Changes
Other Study ID Numbers: Mekos 107P3.2 401
Study First Received: March 16, 2011
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allerderm:
Patch Test
Contact Dermatitis
Allergy
Children
PREA

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

ClinicalTrials.gov processed this record on October 01, 2014