Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00640250|
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : February 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Contact Dermatitis||Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens||Phase 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study|
|Study Start Date :||April 2008|
|Primary Completion Date :||March 2009|
|Study Completion Date :||September 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|