Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Allerderm Laboratories

Status and phase: Completed; Phase 3

Conditions: Contact Dermatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640614

Mekos 07 7P3.2 301

2008-000168-18 (EudraCT Number)

WIRB Pr. No.: 20080089 (Other Identifier)

Details and patient eligibility

About

We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Full description

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:

• Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.
• Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:

• The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.
• The frequency of adverse events and serious adverse events.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).

• Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.

  • Gold sodium thiosulfate
  • Methyldibromoglutaronitrile (alone or with phenoxyethanol)
  • Bacitracin
  • Bronopol
  • Disperse blue 106 (alone or with Disperse blue 124)
  • Parthenolide (or Compositae mix)
  • Hydrocortisone-17-butyrate

• All subjects must be adults over 18 years of age, and otherwise in good health.

• Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine 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 corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
• Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
• Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.
• Treatment with ultraviolet (UV) light (including tanning) during the 21 days before visit
• 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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

Sensitives

Experimental group

Description:

Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.

Treatment:

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

Consecutives

Experimental group

Description:

Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.

Treatment:

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