Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol

Allerderm10 sites in 2 countries235 target enrollmentStarted: April 1, 2008Last updated: May 5, 2020

Conditions

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor
Enrollment: 235
Locations: 10
Primary Endpoint: Diagnostic Performance: Sensitivity and Specificity: Disperse Blue

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed 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:

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Diagnostic
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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
•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
•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).