Trial Outcomes & Findings for Randomized Evaluation of Ten Allergy Skin Prick Test Devices (NCT NCT03509766)

Results Overview

Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

15 minutes

Results posted on

2018-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Skin Testing All subjects both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Skin Testing n=24 Participants All subject both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants
Sex/Gender, Customized Female	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.

Outcome measures

Outcome measures
Measure	Skin Testing n=24 Participants All subjects both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine
Wheal Response	6.8 mm Standard Deviation 0.4

PRIMARY outcome

Timeframe: 15 minutes

Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.

Outcome measures

Outcome measures
Measure	Skin Testing n=24 Participants All subjects both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine
Sensitivity	95.8 percentage of tests true positive

SECONDARY outcome

Timeframe: 15 minutes

Population: All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.

Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.

Outcome measures

Outcome measures
Measure	Skin Testing n=24 Participants All subjects both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine
Skin Prick Techniques/Methodology Ratio	1 ratio Standard Deviation .01

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jody Tversky

Johns Hopkins School of Medicine

Phone: 410-550-5949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place