Trial record 8 of 19 for:    Open Studies | "Dermatitis, Contact"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Allerderm
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT01797562
First received: February 20, 2013
Last updated: December 17, 2013
Last verified: December 2013
  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: Allocation: Non-Randomized
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 (PREA II)

Resource links provided by NLM:


Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Frequency and characterization of positive reactions per allergen. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 100
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: 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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
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: 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    503-494-4662      
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

No publications provided

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT01797562     History of Changes
Other Study ID Numbers: SP 12 7NEW 401
Study First Received: February 20, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allerderm:
Contact dermatitis
Eczema

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Bacitracin
Bronopol
Sodium thiosulfate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Parthenolide
Hydrocortisone
Hydrocortisone-17-butyrate
Gold Sodium Thiosulfate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Inflammatory Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on September 14, 2014