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Completed

NCT Number: NCT01797562

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

The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Eczema Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rady Children's Hospital, San Diego, California, United States

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About this study

The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panels 1.3, 2.2 and 3.2 experimental allergens

Diagnostic Test

Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.

Primary outcomes

  1. Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores

    Time frame: Investigator Determination of Positive Reaction: 21 days post application

    Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction

Secondary outcomes

  1. Number of Participants With Late or Persistent Positive Patch Test Reactions

    Time frame: Day 7-21

    Late reactions are positive reactions that initially occur at 7-21 days after application of the panels.

    Persistent reactions are positive reactions that persist from one visit to the next.

    Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.

Sponsors and collaborators

Lead sponsor

Allerderm

Industry

Registry information

Official study title

Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2013
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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