Back to resultsClinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Primary Purpose
Contact Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Sponsored by
About this trial
This is an interventional diagnostic trial for Contact Dermatitis focused on measuring Dermatitis, Contact, Bronopol, Disperse Blue 106
Eligibility Criteria
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.
Sites / Locations
- Dermatology Specialists PSC
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sensitives
Arm Description
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.
Outcomes
Primary Outcome Measures
Diagnostic Performance: Optimal Test Allergen Concentration
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
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
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
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
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
Concordance Between Investigational Allergen and Reference Allergen
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00640250
Brief Title
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Official Title
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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").
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
Keywords
Dermatitis, Contact, Bronopol, Disperse Blue 106
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensitives
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Other Intervention Name(s)
T.R.U.E. TEST® Skin Patch Test: Panel 3.2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Performance: Optimal Test Allergen Concentration
Description
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Time Frame
Visits 3-5: 3-21 days after application
Title
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Description
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Time Frame
Visit 3: 3 days after application
Title
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Description
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Time Frame
Visit 4: 7 days after application
Title
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Description
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Time Frame
Visit 3: 3 days after application
Title
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Description
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Time Frame
Visit 4: 7 days after application
Title
Concordance Between Investigational Allergen and Reference Allergen
Description
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Time Frame
Visit 5: 21 days after patch application
Secondary Outcome Measure Information:
Title
Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
Description
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
Time Frame
Day 2-21
Title
Adverse Events
Description
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.
Time Frame
Days 0-21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evy Paulsen, M.D., Ph.D
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Fowler, MD
Organizational Affiliation
Dermatology Specialists PSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Specialists PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1864
Country
United States
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
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