Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 4
- Primary Endpoint
- Diagnostic Performance: Optimal Test Allergen Concentration
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens (Biological)
Outcomes
Primary Outcomes
Diagnostic Performance: Optimal Test Allergen Concentration
Time Frame: Visits 3-5: 3-21 days after application
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Concordance Between Investigational Allergen and Reference Allergen
Time Frame: Visit 5: 21 days after patch application
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Time Frame: Visit 4: 7 days after application
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Secondary Outcomes
- Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning(Day 2-21)
- Adverse Events(Days 0-21)