Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

Allerderm Laboratories

Status and phase: Completed; Phase 2

Conditions: Contact Dermatitis

Treatments: Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640250

Mekos 07 2P3.2 201

WIRB Pr. No.: 20072233 (Other Identifier)

2007-007130-19 (EudraCT Number)

Details and patient eligibility

About

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").

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Sensitives

Experimental group

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.

Treatment:

Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens