Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol

We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Study Overview

• Status: Completed
• Conditions: Contact Dermatitis
• Intervention / Treatment: Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Detailed Description

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:

• Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.
• Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:

• The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.
• The frequency of adverse events and serious adverse events.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Odense C, Denmark, DK-5000
    • Odense University Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • River City Dermatology
  • Kansas
    • Shawnee Mission, Kansas, United States, 66216
      • American Dermatology Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40202-1864
      • Dermatology Specialists PSC
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).

• Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.

  • Gold sodium thiosulfate
  • Methyldibromoglutaronitrile (alone or with phenoxyethanol)
  • Bacitracin
  • Bronopol
  • Disperse blue 106 (alone or with Disperse blue 124)
  • Parthenolide (or Compositae mix)
  • Hydrocortisone-17-butyrate
• All subjects must be adults over 18 years of age, and otherwise in good health.
• Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
• Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Exclusion Criteria:

• Subjects unable to meet inclusion requirements.
• Women who are breastfeeding or pregnant.
• Topical corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
• Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
• Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.
• Treatment with ultraviolet (UV) light (including tanning) during the 21 days before visit
• Acute dermatitis outbreak or dermatitis on or near the test area on the back.
• Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensitives; Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens; Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.; Other Names: T.R.U.E. TEST® Skin Patch Test: Panel 3.2
Experimental: Consecutives; Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens; Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.; Other Names: T.R.U.E. TEST® Skin Patch Test: Panel 3.2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.	Visit 5: 21 days after patch application
Diagnostic Performance: Concordance	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate	Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bacitracin	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Parthenolide	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bronopol	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen	Visit 5: 21 days after patch application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluations: All T.R.U.E. Test Allergens	Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.	Day 2: 48 hours after application
Late Reactions: All T.R.U.E. Test Allergens	Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).	7-10 days after patch application
Persistent Reactions: All T.R.U.E. Test Allergens	Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)	initially occur 2-4 days after application and last through 7-21days after patch application

Collaborators and Investigators

• Sponsor: Allerderm
• Investigators: Principal Investigator: Luz Fonacier, MD, Winthrop University; Principal Investigator: Donald V Belsito, MD, American Dermatology Associates; Principal Investigator: Jerri Hoskyn, MD, Rivery City Dermatology; Principal Investigator: Sandy Skotnicki-Grant, MD, Bay Dermatology Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Dermatitis, Contact
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: Mekos 07 7P3.2 301; 2008-000168-18 (EudraCT Number); WIRB Pr. No.: 20080089 (Other Identifier: Western Institutional Review Board)