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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640614

Enrollment

235

Registered

2008-03-21

Start date

2008-04-30

Completion date

2009-10-31

Last updated

2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Dermatitis

Keywords

Dermatitis, Contact

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.

Interventions

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

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 * 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).

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Performance: Sensitivity and Specificity: Bronopol	Visit 5: 21 days after patch application	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	Visit 5: 21 days after patch application	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	Visit 5: 21 days after patch application	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	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21	Visit 5: 21 days after patch application	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
Diagnostic Performance: Concordance	Visit 5: 21 days after patch application	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate	Visit 5: 21 days after patch application	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	Visit 5: 21 days after patch application	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	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Secondary

Measure	Time frame	Description
Late Reactions: All T.R.U.E. Test Allergens	7-10 days after patch application	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	initially occur 2-4 days after application and last through 7-21days after patch application	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)
Safety Evaluations: All T.R.U.E. Test Allergens	Day 2: 48 hours after application	Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.

Countries

Denmark, United States

Participant flow

Recruitment details

3 June 2008 through 17 August 2009

Pre-assignment details

There were no significant events or approaches for the overall study following enrollment but prior to group assignment.

Participants by arm

Arm	Count
Sensitives 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.	125
Consecutives Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.	110
Total	235

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Sensitives	Consecutives	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	28 Participants	21 Participants	49 Participants
Age, Categorical Between 18 and 65 years	97 Participants	89 Participants	186 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 14.93	51.2 years STANDARD_DEVIATION 14.75	50.4 years STANDARD_DEVIATION 14.75
Region of Enrollment Canada	0 participants	23 participants	23 participants
Region of Enrollment Denmark	28 participants	2 participants	30 participants
Region of Enrollment United States	97 participants	85 participants	182 participants
Sex: Female, Male Female	79 Participants	78 Participants	157 Participants
Sex: Female, Male Male	46 Participants	32 Participants	78 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	8 / 125	2 / 110
serious Total, serious adverse events	0 / 125	0 / 110

Outcome results

Primary

Diagnostic Performance: Concordance

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