Trial Outcomes & Findings for Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations (NCT NCT00612768)

NCT ID: NCT00612768

Last Updated: 2018-04-09

Results Overview

Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Up to 21 days
• Results posted on: 2018-04-09

Participant Flow

The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.

No subject was excluded from the trial following enrollment but before assignment to a group.

Participant milestones

Measure	Sensitive Subjects All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

Baseline characteristics by cohort

Measure	Sensitive Subjects n=50 Participants Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 16.72 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: The data from 50 subjects enrolled in the study was analyzed

Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit

Outcome measures

Measure	Fragrance Mix n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Thimerosol n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Sensitivity: Thimerosal in HPC Agreement between positive results for the test and reference allergen	Sensitivity: Thimerosol in PVP Agreement between positive results for the test and reference allergen	Specificity: Fragrance Mix in HPC Agreement between negative results for the test and reference allergen	Specificity: Fragrance Mix in PVP Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in HPC Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in PVP Agreement between negative results for the test and reference allergen
Analysis of Bioequivalence: Concordance	76 percentage of agreement Interval 61.8 to 86.9	98.0 percentage of agreement Interval 89.4 to 99.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 21 days

Population: The data from all enrolled subjects was analyzed.

Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen

Outcome measures

Measure	Fragrance Mix n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Thimerosol n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Sensitivity: Thimerosal in HPC n=50 Participants Agreement between positive results for the test and reference allergen	Sensitivity: Thimerosol in PVP n=50 Participants Agreement between positive results for the test and reference allergen	Specificity: Fragrance Mix in HPC n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Fragrance Mix in PVP n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in HPC n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in PVP n=50 Participants Agreement between negative results for the test and reference allergen
Agreement Between TRUE Test Allergen and Reference Allergen	40.9 percentage of agreement Interval 20.7 to 63.6	59.1 percentage of agreement Interval 36.4 to 79.3	61.5 percentage of agreement Interval 40.6 to 79.8	65.4 percentage of agreement Interval 44.3 to 82.8	92.9 percentage of agreement Interval 76.5 to 99.1	100 percentage of agreement Interval 87.7 to 100.0	100 percentage of agreement Interval 85.8 to 100.0	100 percentage of agreement Interval 85.8 to 100.0

SECONDARY outcome

Timeframe: Visit 2: 48 hours after patch application

Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.

Outcome measures

Measure	Fragrance Mix n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Thimerosol n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Sensitivity: Thimerosal in HPC n=50 Participants Agreement between positive results for the test and reference allergen	Sensitivity: Thimerosol in PVP n=50 Participants Agreement between positive results for the test and reference allergen	Specificity: Fragrance Mix in HPC Agreement between negative results for the test and reference allergen	Specificity: Fragrance Mix in PVP Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in HPC Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in PVP Agreement between negative results for the test and reference allergen
Irritation, Adhesion, Itching/Burning	28 percentage of participants	24 percentage of participants	20 percentage of participants	46 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 (48 hours after application) through Day 21

Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application

Outcome measures

Measure	Fragrance Mix n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Thimerosol n=50 Participants Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Sensitivity: Thimerosal in HPC n=50 Participants Agreement between positive results for the test and reference allergen	Sensitivity: Thimerosol in PVP n=50 Participants Agreement between positive results for the test and reference allergen	Specificity: Fragrance Mix in HPC n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Fragrance Mix in PVP n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in HPC n=50 Participants Agreement between negative results for the test and reference allergen	Specificity: Thimerosal in PVP n=50 Participants Agreement between negative results for the test and reference allergen
Frequency of Late and Persistent Reactions	0 percentage of subjects with reactions	0 percentage of subjects with reactions	0 percentage of subjects with reactions	0 percentage of subjects with reactions	0 percentage of subjects with reactions	0 percentage of subjects with reactions	4 percentage of subjects with reactions	4 percentage of subjects with reactions

Adverse Events

Sensitives

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sensitives n=50 participants at risk subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
Cardiac disorders Right femoral sheath placed secondary to tronsientischemic attack/carotid stenosis	2.0% 1/50 • Number of events 1 • Day 0-21

Other adverse events

Measure	Sensitives n=50 participants at risk subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
Gastrointestinal disorders Bladder Infection	2.0% 1/50 • Day 0-21
Skin and subcutaneous tissue disorders Itching	2.0% 1/50 • Day 0-21
Skin and subcutaneous tissue disorders Itching and burning	2.0% 1/50 • Day 0-21
Skin and subcutaneous tissue disorders Itching on/around site	2.0% 1/50 • Day 0-21
Skin and subcutaneous tissue disorders Reports burning sensation, she thinks it might be due to the tape	2.0% 1/50 • Day 0-21
Skin and subcutaneous tissue disorders Itching at positive patch sites	2.0% 1/50 • Day 0-21

Additional Information

Kathy Shannon

SmartPractice

Phone: 602-225-0595

Email: kshannon@smarthealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place