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

Primary Purpose

Contact Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Contact Dermatitis focused on measuring Dermatitis, Contact

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

River City Dermatology
American Dermatology Associates
Dermatology Specialists PSC
Winthrop University Hospital
Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sensitives

Consecutives

Arm 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.

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

Outcomes

Primary Outcome Measures

Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.

Diagnostic Performance: Concordance

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.

Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate

Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Bacitracin

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Parthenolide

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Disperse Blue

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Diagnostic Performance: Sensitivity and Specificity: Bronopol

The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Secondary Outcome Measures

Safety Evaluations: All T.R.U.E. Test Allergens

Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.

Late Reactions: All T.R.U.E. Test Allergens

Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).

Persistent Reactions: All T.R.U.E. Test Allergens

Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)

Full Information

NCT ID

NCT00640614

First Posted

March 3, 2008

Last Updated

April 21, 2020

Sponsor

Allerderm

1. Study Identification

Unique Protocol Identification Number

NCT00640614

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allerderm

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contact Dermatitis

Keywords

Dermatitis, Contact

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

235 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sensitives

Arm Type

Experimental

Arm 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.

Arm Title

Consecutives

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

T.R.U.E. TEST® Skin Patch Test: Panel 3.2

Intervention Description

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP 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.

Primary Outcome Measure Information:

Title

Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21

Description

Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen

Time Frame