Clinical trial NCT00640250: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contact Dermatitis
Keywords: Dermatitis, Contact, Bronopol, Disperse Blue 106
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic Performance: Optimal Test Allergen Concentration
timeFrame: Visits 3-5: 3-21 days after application
measure: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
timeFrame: Visit 3: 3 days after application
measure: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
timeFrame: Visit 4: 7 days after application
measure: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
timeFrame: Visit 3: 3 days after application
measure: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
timeFrame: Visit 4: 7 days after application
measure: Concordance Between Investigational Allergen and Reference Allergen
timeFrame: Visit 5: 21 days after patch application
Secondary outcomes:
measure: Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
timeFrame: Day 2-21
measure: Adverse Events
timeFrame: Days 0-21
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists PSC
state: Kentucky
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Evy Paulsen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists PSC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: