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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT00640614
First received: March 3, 2008
Last updated: November 18, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Contact Dermatitis
Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.

  • Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    Number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Bacitracin [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Parthenolide [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Disperse Blue [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

  • Diagnostic Performance: Sensitivity and Specificity: Bronopol [ Time Frame: Visit 5: 21 days after patch application ] [ Designated as safety issue: No ]
    The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen


Secondary Outcome Measures:
  • Safety Evaluations: All T.R.U.E. Test Allergens [ Time Frame: Day 2: 48 hours after application ] [ Designated as safety issue: Yes ]
    Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.

  • Late Reactions: All T.R.U.E. Test Allergens [ Time Frame: 7-10 days after patch application ] [ Designated as safety issue: Yes ]
    Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).

  • Persistent Reactions: All T.R.U.E. Test Allergens [ Time Frame: initially occur 2-4 days after application and last through 7-21days after patch application ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 235
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: T.R.U.E. TEST® Skin Patch Test: Panel 3.2

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640614

Locations
United States, Arkansas
River City Dermatology
Little Rock, Arkansas, United States, 72205
United States, Kansas
American Dermatology Associates
Shawnee, Kansas, United States, 66216
United States, Kentucky
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202-1864
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Denmark
Odense University Hospital
Odense C, Denmark, DK-5000
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: 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
  More Information

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT00640614     History of Changes
Other Study ID Numbers: Mekos 07 7P3.2 301  2008-000168-18  WIRB Pr. No.: 20080089 
Study First Received: March 3, 2008
Results First Received: February 21, 2013
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Allerderm:
Dermatitis, Contact

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Parthenolide
Hydrocortisone
Sodium thiosulfate
Bacitracin
Bronopol
Hydrocortisone-17-butyrate
Gold Sodium Thiosulfate
Anti-Inflammatory Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents
Anti-Infective Agents, Local
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 28, 2016