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

NCT00640614 | Completed Phase 3 Results

• 3 other identifiers: Mekos 07 7P3.2 3012008-000168-18WIRB Pr. No.: 20080089
• Study Type: interventional
• Target: 235
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Contact Dermatitis

Keywords

Dermatitis, Contact

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (3)

• Safety Evaluations: All T.R.U.E. Test Allergens

  Day 2: 48 hours after application

• Late Reactions: All T.R.U.E. Test Allergens

  7-10 days after patch application

• Persistent Reactions: All T.R.U.E. Test Allergens

  initially occur 2-4 days after application and last through 7-21days after patch application

Study Arms (2)

Sensitives

EXPERIMENTAL

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

Consecutives

EXPERIMENTAL

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

Interventions

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens BIOLOGICAL

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.

Also known as: T.R.U.E. TEST® Skin Patch Test: Panel 3.2

Consecutives; Sensitives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Allerderm: lead

Study Sites (5)

River City Dermatology

Little Rock, Arkansas, 72205, United States

Location

American Dermatology Associates

Shawnee Mission, Kansas, 66216, United States

Location

Dermatology Specialists PSC

Louisville, Kentucky, 40202-1864, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Odense University Hospital

Odense C, DK-5000, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Kim Sullivan
• Organization: Allerderm

602-225-0595

Study Officials

• Evy Paulsen, M.D., Ph.D

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Joseph Fowler, MD

  Dermatology Specialists PSC

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 5, 2020
• Results First Posted: December 22, 2015

Record last verified: 2020-04

Locations

US (4); DK (1)