Trial Outcomes & Findings for Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response (NCT NCT00640250)
NCT ID: NCT00640250
Last Updated: 2018-04-09
Results Overview
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Visits 3-5: 3-21 days after application
Results posted on
2018-04-09
Participant Flow
Dates of recruitment: 16 June 2008 through 7 April 2009. This study was conducted at two investigational sites located in Denmark (E Paulsen) and the United States (J Fowler).
There were no significant events or approaches which caused enrolled participants to be excluded from the trial before assignment to a group.
Participant milestones
| Measure |
Sensitives
Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Baseline characteristics by cohort
| Measure |
Sensitives
n=48 Participants
Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visits 3-5: 3-21 days after applicationPopulation: Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Diagnostic Performance: Optimal Test Allergen Concentration
|
38.1 percentage of participants
|
47.6 percentage of participants
|
52.4 percentage of participants
|
30.8 percentage of participants
|
23.1 percentage of participants
|
46.2 percentage of participants
|
61.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 3: 3 days after applicationPopulation: All subjects
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
n=48 Participants
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
|
16.7 percentage of participants
Interval 7.5 to 30.2
|
18.8 percentage of participants
Interval 8.9 to 32.6
|
25.0 percentage of participants
Interval 13.6 to 39.6
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
75.0 percentage of participants
Interval 60.4 to 86.4
|
77.1 percentage of participants
Interval 62.7 to 88.0
|
72.9 percentage of participants
Interval 58.2 to 84.7
|
91.7 percentage of participants
Interval 80.0 to 97.7
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 4: 7 days after applicationPercent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
n=48 Participants
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
n=48 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
n=48 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
|
18.8 percentage of participants
Interval 8.9 to 32.6
|
18.8 percentage of participants
Interval 8.9 to 32.6
|
27.1 percentage of participants
Interval 15.3 to 41.8
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
75.0 percentage of participants
Interval 60.4 to 86.4
|
72.9 percentage of participants
Interval 58.2 to 84.7
|
70.8 percentage of participants
Interval 55.9 to 83.0
|
97.9 percentage of participants
Interval 88.9 to 99.9
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 3: 3 days after applicationPopulation: Data from one subject not included because subject did not have a past positive response to either allergen.
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
n=47 Participants
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
|
14.6 percentage of participants
Interval 6.1 to 27.8
|
14.6 percentage of participants
Interval 6.1 to 27.8
|
25.0 percentage of participants
Interval 13.6 to 39.6
|
45.8 percentage of participants
Interval 31.4 to 60.8
|
79.2 percentage of participants
Interval 65.0 to 89.5
|
72.9 percentage of participants
Interval 58.2 to 84.7
|
58.3 percentage of participants
Interval 43.2 to 72.4
|
37.5 percentage of participants
Interval 24.0 to 52.6
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
12.5 percentage of participants
Interval 4.7 to 25.2
|
14.6 percentage of participants
Interval 6.1 to 27.8
|
16.7 percentage of participants
Interval 7.5 to 30.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 4: 7 days after applicationPopulation: Data from one subject not included because subject did not have past positive response to either allergen.
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=47 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
n=47 Participants
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
n=47 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
n=47 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
|
14.9 percentage of participants
Interval 6.2 to 28.3
|
17.0 percentage of participants
Interval 7.6 to 30.8
|
21.3 percentage of participants
Interval 10.7 to 35.7
|
29.8 percentage of participants
Interval 17.3 to 44.9
|
78.7 percentage of participants
Interval 64.3 to 89.3
|
74.5 percentage of participants
Interval 59.7 to 86.1
|
59.6 percentage of participants
Interval 44.3 to 73.6
|
57.4 percentage of participants
Interval 42.2 to 71.7
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
4.3 percentage of participants
Interval 0.5 to 14.5
|
8.5 percentage of participants
Interval 2.4 to 20.4
|
6.4 percentage of participants
Interval 1.3 to 17.5
|
8.5 percentage of participants
Interval 2.4 to 20.4
|
14.9 percentage of participants
Interval 6.2 to 28.3
|
4.3 percentage of participants
Interval 0.5 to 14.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 5: 21 days after patch applicationPopulation: Data from one subject not included because subject did not have past positive response to either allergen.
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concordance Between Investigational Allergen and Reference Allergen
|
81.0 percentage of agreement
Interval 58.1 to 94.6
|
95.2 percentage of agreement
Interval 76.2 to 99.9
|
90.5 percentage of agreement
Interval 69.6 to 98.8
|
84.6 percentage of agreement
Interval 65.1 to 95.6
|
100.0 percentage of agreement
Interval 86.8 to 100.0
|
76.9 percentage of agreement
Interval 56.4 to 91.0
|
61.5 percentage of agreement
Interval 40.6 to 79.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2-21Population: Data from one subject not included because subject did not have past positive response to either allergen.
Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. 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 |
Disperse Blue 0.017 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
n=26 Participants
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
n=21 Participants
Percentage of positive test responses
|
Negative Control Negative Reactions
n=21 Participants
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
n=21 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
n=21 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
n=21 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
n=21 Participants
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
n=26 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
n=26 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
n=26 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
n=26 Participants
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
n=26 Participants
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
n=26 Participants
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
n=26 Participants
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
n=26 Participants
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
|
71.4 percentage of participants
|
65.4 percentage of participants
|
76.2 percentage of participants
|
73.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
19.0 percentage of participants
|
19.0 percentage of participants
|
28.6 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.5 percentage of participants
|
15.4 percentage of participants
|
11.5 percentage of participants
|
11.5 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-21The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.
Outcome measures
| Measure |
Disperse Blue 0.017 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.050 mg/cm2
n=48 Participants
Percentage of positive test responses
|
Disperse Blue 0.150 mg/cm2
Percentage of positive test responses
|
Bronopol 0.125 mg/cm2
Percentage of positive test responses
|
Bronopol 0.250 mg/cm2
Percentage of positive test responses
|
Bronopol 0.500 mg/cm2
Percentage of positive test responses
|
Bronopol 0.750 mg/cm2
Percentage of positive test responses
|
Negative Control Negative Reactions
Percentage of subjects who exhibited negative reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Negative Control Irritant Reactions
Percentage of subjects who exhibited irritant reactions at visit 3
|
Disperse Blue 0.017 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.050 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Disperse Blue 0.150 mg/cm2 Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Negative Control Doubtful Reactions
Percentage of subjects who exhibited doubtful reactions at visit 3
|
Bronopol 0.125 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.250 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.500 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
Bronopol 0.750 mg/cm2 Persistent Reactions
Percentage of subjects who exhibited persistent reactions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events
|
1 events
|
1 events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
All Subjects
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 |
All Subjects
n=48 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Upset stomach
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 21
Serious or possibly related events were to be followed until they resolved or assessed as chronic or stable
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 21
Serious or possibly related events were to be followed until they resolved or assessed as chronic or stable
|
Additional Information
Evy Paulsen, MD
Institute of Clinical Research, Department of Dermoto Venerology and Allergy Center
Phone: +45 65 41 27 08
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place