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

NCT00795951 | Completed Phase 4 Results

• 1 other identifier: MEKOS 07 29P1/2/3/401
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatitis, Contact

Keywords

allergic; contact dermatitis; contact allergy; Type IV; Children; TRUE TEST

Outcome Measures

Primary Outcomes (29)

• Positive Reactions: Nickel Sulfate

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

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

• Positive Reactions: Neomycin Sulfate

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

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

• Positive Reactions: Wool Alcohol

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

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

• Positive Reactions: Potassium Dichromate

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

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

• Positive Reactions: Caine Mix

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

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

• Positive Reactions: Fragrance Mix

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

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

• Positive Reactions: Colophony

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

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

• Positive Reactions: Paraben Mix

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

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

• Positive Reactions: Negative Control

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

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

• Positive Reactions: Balsam of Peru

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

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

• Positive Reactions: Ethylenediamine Dihydrochloride

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

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

• Positive Reactions: Cobalt Dichloride

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

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

• Positive Reactions: P-tert Butylphenol Formadehyde Resin

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

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

• Positive Reactions: Epoxy Resin

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

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

• Positive Reactions: Carba Mix

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

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

• Positive Reactions: Black Rubber Mix

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

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

• Positive Reactions: Cl+Me-Isothiazolinone

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

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

• Positive Reactions: Quaternium-15

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

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

• Positive Reactions: Mercaptobenzothiazole

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

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

• Positive Reactions: p-Phenylenediamine

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

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

• Positive Reactions: Formaldehyde

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

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

• Positive Reactions: Mercapto Mix

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

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

• Positive Reactions: Thimerosal

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

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

• Positive Reactions: Thiuram Mix

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

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

• Positive Reactions: Diazolidinyl Urea

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

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

• Positive Reactions: Imidazolidinyl Urea

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

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

• Positive Reactions: Budesonide

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

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

• Positive Reactions: Tixocortol-21-pivalate

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

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

• Positive Reactions: Quinoline Mix

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

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

Secondary Outcomes (61)

• Late Reactions: Nickel Sulfate

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

• Late Reactions: Neomycin Sulfate

  Visit 4: 7 days after patch application

• Late Reactions: Wool Alcohol

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

• Late Reactions: Potassium Dichromate

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

• Late Reactions: Caine Mix

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

Study Arms (1)

TRUE Test panels 1.1, 2.1, 3.1

EXPERIMENTAL

All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.

Biological: T.R.U.E. Test

Interventions

T.R.U.E. Test BIOLOGICAL

48 hour application of 28 allergens and negative control

Also known as: NA no other names

TRUE Test panels 1.1, 2.1, 3.1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allerderm: lead

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: SE Jacob, MD and L Eichenfield, MD
• Organization: Rady Children's Hospital, San Diego, CA

leichenfield@rchsd.org

858-576-1700

Study Officials

• Lawrence Eichenfield, MD

  UCSD School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 6, 2020
• Results First Posted: February 11, 2014

Record last verified: 2013-12

Locations

US (1)