Trial Outcomes & Findings for Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy (NCT NCT00640614)

NCT ID: NCT00640614

Last Updated: 2020-05-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 235 participants
• Primary outcome timeframe: Visit 5: 21 days after patch application
• Results posted on: 2020-05-05

Participant Flow

3 June 2008 through 17 August 2009

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

Participant milestones

Measure	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.	Consecutives Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
Overall Study STARTED	125	110
Overall Study COMPLETED	124	110
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	Consecutives Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sensitives n=125 Participants 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.	Consecutives n=110 Participants Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.	Total n=235 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	89 Participants n=7 Participants	186 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	21 Participants n=7 Participants	49 Participants n=5 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 14.93 • n=5 Participants	51.2 years STANDARD_DEVIATION 14.75 • n=7 Participants	50.4 years STANDARD_DEVIATION 14.75 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	78 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	32 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants	85 participants n=7 Participants	182 participants n=5 Participants
Region of Enrollment Canada	0 participants n=5 Participants	23 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Denmark	28 participants n=5 Participants	2 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to gold sodium thiosulfate

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

Outcome measures

Measure	Concordance n=19 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21	78.9 percentage of concordant responses Interval 54.4 to 93.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to hydrocortizone-17-butyrate

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

Outcome measures

Measure	Concordance n=20 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	90 percentage of concordant responses Interval 68.3 to 96.6	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to methyldibromo-glutaronitrile

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

Outcome measures

Measure	Concordance n=29 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	62.1 percentage of concordant responses Interval 42.3 to 79.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to bacitracin

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

Outcome measures

Measure	Concordance n=24 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	75 percentage of concordant responses Interval 53.3 to 90.2	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to parthenolide

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

Outcome measures

Measure	Concordance n=18 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	94.4 percentage of concordant responses Interval 72.7 to 99.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive patch test results to disperse blue

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

Outcome measures

Measure	Concordance n=17 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	82.2 percentage of concordant responses Interval 63.6 to 98.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Visit 5: 21 days after patch application

Population: Subjects with past positive test results to bronopol

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

Outcome measures

Measure	Concordance n=23 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Concordance	82.6 percentage of concordant responses Interval 61.2 to 95.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=16 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=16 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate	100 percentage of agreement Interval 73.5 to 100.0	57.1 percentage of agreement Interval 18.4 to 90.1	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=20 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=20 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate	92.3 percentage of agreement Interval 64.0 to 99.8	85.7 percentage of agreement Interval 42.1 to 99.6	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=29 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=29 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile	28.6 percentage of agreement Interval 8.4 to 58.1	93.3 percentage of agreement Interval 68.1 to 99.8	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=24 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=24 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Bacitracin	92.9 percentage of agreement Interval 66.1 to 99.8	50 percentage of agreement Interval 18.7 to 81.3	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=18 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=18 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Parthenolide	92.9 percentage of agreement Interval 66.1 to 99.8	100 percentage of agreement Interval 39.8 to 100.0	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=15 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=15 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue	88.9 percentage of agreement Interval 51.8 to 99.7	87.5 percentage of agreement Interval 47.3 to 99.7	—	—	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Concordance n=23 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=23 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Diagnostic Performance: Sensitivity and Specificity: Bronopol	100 percentage of agreement Interval 39.8 to 100.0	78.9 percentage of agreement Interval 54.4 to 93.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 2: 48 hours after application

Population: NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects.

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

Outcome measures

Measure	Concordance n=235 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=235 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion n=235 Participants Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin Number of subjects who exhibit reactions 7-10 days after application	Parthenolide Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue Number of subjects who exhibit reactions 7-10 days after application	Bronopol Number of subjects who exhibit reactions 7-10 days after application
Safety Evaluations: All T.R.U.E. Test Allergens	79 participants	123 participants	4 participants	—	—	—	—

SECONDARY outcome

Timeframe: 7-10 days after patch application

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

Outcome measures

Measure	Concordance n=234 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=234 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion n=234 Participants Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Parthenolide n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Bronopol n=234 Participants Number of subjects who exhibit reactions 7-10 days after application
Late Reactions: All T.R.U.E. Test Allergens	6 participants	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Concordance n=234 Participants Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.	Specificity n=234 Participants The agreement between the negative results for gold sodium thiosulfate and the reference allergen	Adhesion n=234 Participants Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.	Bacitracin n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Parthenolide n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Disperse Blue n=234 Participants Number of subjects who exhibit reactions 7-10 days after application	Bronopol n=234 Participants Number of subjects who exhibit reactions 7-10 days after application
Persistent Reactions: All T.R.U.E. Test Allergens	26 participants	6 participants	4 participants	3 participants	12 participants	5 participants	5 participants

Adverse Events

Sensitives

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Consecutives

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sensitives n=125 participants at risk 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.	Consecutives n=110 participants at risk Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
Musculoskeletal and connective tissue disorders Bruise on mid sternum from motor vehicle accident	0.00% 0/125 • Day 1 through Day 21	0.91% 1/110 • Number of events 1 • Day 1 through Day 21
Respiratory, thoracic and mediastinal disorders Upper respiratory congestion	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Respiratory, thoracic and mediastinal disorders Common head cold symptoms	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Respiratory, thoracic and mediastinal disorders Asthma	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Gastrointestinal disorders Laparoscopic cholecystectomy	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Musculoskeletal and connective tissue disorders Right thumb trauma	0.00% 0/125 • Day 1 through Day 21	0.91% 1/110 • Number of events 1 • Day 1 through Day 21
Skin and subcutaneous tissue disorders Pruritus	1.6% 2/125 • Number of events 2 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Skin and subcutaneous tissue disorders Intense itching	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Skin and subcutaneous tissue disorders Intense itching ++ and +++ reactions	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21
Skin and subcutaneous tissue disorders Flare of pre-existing hand eczema during first 3 days of testing	0.80% 1/125 • Number of events 1 • Day 1 through Day 21	0.00% 0/110 • Day 1 through Day 21

Additional Information

Kim Sullivan

Allerderm

Phone: 602-225-0595

Results disclosure agreements

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