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Completed

NCT Number: NCT00795951

Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rady Children's Hospital

San Diego, California, 92123, United States

About this study

Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

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 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 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 immunosuppressive 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

T.R.U.E. Test

Biological

48 hour application of 28 allergens and negative control

Other names: NA no other names

Primary outcomes

  1. Positive Reactions: Nickel Sulfate

    Time frame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4

  2. Positive Reactions: Neomycin Sulfate

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4

  3. Positive Reactions: Wool Alcohol

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  4. Positive Reactions: Potassium Dichromate

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  5. Positive Reactions: Caine Mix

    Time frame: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  6. Positive Reactions: Fragrance Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  7. Positive Reactions: Colophony

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  8. Positive Reactions: Paraben Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  9. Positive Reactions: Negative Control

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4.

  10. Positive Reactions: Balsam of Peru

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  11. Positive Reactions: Ethylenediamine Dihydrochloride

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  12. Positive Reactions: Cobalt Dichloride

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  13. Positive Reactions: P-tert Butylphenol Formadehyde Resin

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  14. Positive Reactions: Epoxy Resin

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  15. Positive Reactions: Carba Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  16. Positive Reactions: Black Rubber Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  17. Positive Reactions: Cl+Me-Isothiazolinone

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  18. Positive Reactions: Quaternium-15

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  19. Positive Reactions: Mercaptobenzothiazole

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  20. Positive Reactions: p-Phenylenediamine

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  21. Positive Reactions: Formaldehyde

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  22. Positive Reactions: Mercapto Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions at visit 3 and/or visit 4

  23. Positive Reactions: Thimerosal

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  24. Positive Reactions: Thiuram Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  25. Positive Reactions: Diazolidinyl Urea

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  26. Positive Reactions: Imidazolidinyl Urea

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions at visit 3 and/or visit 4

  27. Positive Reactions: Budesonide

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

  28. Positive Reactions: Tixocortol-21-pivalate

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions at visit 3 and/or visit 4

  29. Positive Reactions: Quinoline Mix

    Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

    Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Secondary outcomes

  1. Late Reactions: Nickel Sulfate

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  2. Late Reactions: Neomycin Sulfate

    Time frame: Visit 4: 7 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  3. Late Reactions: Wool Alcohol

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  4. Late Reactions: Potassium Dichromate

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  5. Late Reactions: Caine Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  6. Late Reactions: Fragrance Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  7. Late Reactions: Colophony

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  8. Late Reactions: Paraben Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  9. Late Reactions: Negative Control

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  10. Late Reactions: Balsam of Peru

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  11. Late Reactions: Ethylenediamine Dihydrochloride

    Time frame: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  12. Late Reactions: Cobalt Dichloride

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  13. Late Reactions: P-tert Butylphenol Formadehyde Resin

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  14. Late Reactions: Epoxy Resin

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  15. Late Reactions: Carba Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  16. Late Reactions: Black Rubber Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  17. Late Reactions: Cl+Me-Isothiazolinone

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  18. Late Reactions: Quaternium-15

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  19. Late Reactions: Mercaptobenzothiazole

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  20. Late Reactions: p-Phenylenediamine

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  21. Late Reactions: Formaldehyde

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  22. Late Reactions: Mercapto Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  23. Late Reactions: Thimerosal

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  24. Late Reactions: Thiuram Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  25. Late Reactions: Diazolidinyl Urea

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  26. Late Reactions: Imidazolidinyl Urea

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  27. Late Reactions: Budesonide

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  28. Late Reactions: Tixocortol-21-pivalate

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  29. Late Reactions: Quinoline Mix

    Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

    Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

  30. Persistent Reactions: Nickel Sulfate

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  31. Persistent Reactions: Neomycin Sulfate

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  32. Persistent Reactions: Wool Alcohol

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  33. Persistent Reactions: Potassium Dichromate

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  34. Persistent Reactions: Caine Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  35. Persistent Reactions: Fragrance Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  36. Persistent Reactions: Colophony

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  37. Persistent Reactions: Paraben Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  38. Persistent Reactions: Negative Control

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  39. Persistent Reactions: Balsam of Peru

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  40. Persistent Reactions: Ethylenediamine Dihydrochloride

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  41. Persistent Reactions: Cobalt Dichloride

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  42. Persistent Reactions: P-tert Butylphenol Formadehyde Resin

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  43. Persistent Reactions: Epoxy Resin

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  44. Persistent Reactions: Carba Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  45. Persistent Reactions: Black Rubber Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  46. Persistent Reactions: Cl+Me-Isothiazolinone

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  47. Persistent Reactions: Quaternium-15

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  48. Persistent Reactions: p-Phenylenediamine

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  49. Persistent Reactions: Formaldehyde

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  50. Persistent Reactions: Mercapto Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  51. Persistent Reactions: Thimerosal

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  52. Persistent Reactions: Thiuram Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  53. Persistent Reactions: Diazolidinyl Urea

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  54. Persistent Reactions: Imidazolidinyl Urea

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  55. Persistent Reactions: Budesonide

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  56. Persistent Reactions: Tixocortol-21-pivalate

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  57. Persistent Reactions: Quinoline Mix

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  58. Persistent Reactions: Mercaptobenzothiazole

    Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

    Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

  59. Panel Adhesion Evaluation

    Time frame: Visit 2 (day 1) prior to panel removal.

    Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.

  60. Panel Irritation

    Time frame: Visit 2 (day 1) following to panel removal.

    Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)

  61. Subject Reported Itching and Burning

    Time frame: Visit 2 (day 1) following to panel removal.

    Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)

Sponsors and collaborators

Lead sponsor

Allerderm

Industry

Registry information

Official study title

Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
Aug 6, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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