Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").

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:

To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

• Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
• Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
• Concordance/discordance as compared to the corresponding reference petrolatum allergen.

Secondary endpoint:

To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Odense C, Denmark, DK-5000
    • Odense University Hospital
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202-1864
      • Dermatology Specialists PSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.
• All subjects must be adults (18 years of age or older) and otherwise in good health.
• Premenopausal female subjects must consent to a urine pregnancy 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 treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
• Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
• 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 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).
• Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Sensitives; Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.

Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens; Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 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: Optimal Test Allergen Concentration	Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects	Visits 3-5: 3-21 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration	Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects	Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration	Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects	Visit 4: 7 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration	Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects	Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration	Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects	Visit 4: 7 days after application
Concordance Between Investigational Allergen and Reference Allergen	Concordance between disperse blue or bronopol and the respective reference petrolatum allergen	Visit 5: 21 days after patch application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning	Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application	Day 2-21
Adverse Events	The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.	Days 0-21

Collaborators and Investigators

• Sponsor: Allerderm

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (ESTIMATE): March 21, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Dermatitis, Contact, Bronopol, Disperse Blue 106
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: Mekos 07 2P3.2 201; 2007-007130-19 (EUDRACT_NUMBER); WIRB Pr. No.: 20072233 (OTHER: Western Institutional Review Board)