Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
|Contact Dermatitis||Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens||Phase 2|
|Study Design:||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: Bronopol and Disperse Blue 106 Dose Response Study|
- Determination of optimal test concentration for Disperse Blue 106 and Bronopol as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects. [ Time Frame: End of Study ]
- Frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen and concentration. [ Time Frame: End of study ]
|Study Start Date:||April 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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 Name: T.R.U.E. TEST® Skin Patch Test: Panel 3.2
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640250
|United States, Kentucky|
|Dermatology Specialists PSC|
|Louisville, Kentucky, United States, 40202-1864|
|Odense University Hospital|
|Odense C, Denmark, DK-5000|
|Principal Investigator:||Evy Paulsen, M.D., Ph.D||Odense University Hospital|
|Principal Investigator:||Joseph Fowler, MD||Dermatology Specialists PSC|