Trial Outcomes & Findings for Clinical Evaluation of Metal Panel Allergens: Dose Response Study (NCT NCT02615249)
NCT ID: NCT02615249
Last Updated: 2020-08-25
Results Overview
Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
21 days post patch application
Results posted on
2020-08-25
Participant Flow
The study population will consist of subjects with past positive patch test result to at least one of the dilution series metals being tested on this study or strong suspicion of metal contact allergy.
Subjects with a past positive patch test will be tested with the allergen panel and corresponding reference allergen(s) to which they had the previous response. Subjects with suspicion of metal contact allergy will be tested with all dilution series and reference allergens. Not all subjects tested all allergens
Participant milestones
| Measure |
All Subjects
All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
121
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Subjects
All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Clinical Evaluation of Metal Panel Allergens: Dose Response Study
Baseline characteristics by cohort
| Measure |
All Subjects
n=122 Participants
All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
|
|---|---|
|
Age, Continuous
|
60.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin/South American/Caribbean
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
North American
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
30 participants
n=5 Participants
|
|
Subjects with past allergic response or suspicion of allergy
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days post patch applicationPopulation: Not all subjects tested all panels. No of subjects testing each panel; Panel 1- 105, Panel 2-111, Panel 3- 104, Panel 4- 109, Panel 5- 106
Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit.
Outcome measures
| Measure |
All Subjects
n=121 Participants
All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. Allergen response pattern included number of positive responses that were late (initially observed at day 7 or later) or persistent (positive response that persisted from one study visit to the next) and number of negative responses that were doubtful or irritant.
|
|---|---|
|
Number of Participants With Patch Test Responses
0.40 mg/cm2 aluminum chloride · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.40 mg/cm2 aluminum chloride · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.40 mg/cm2 aluminum chloride · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 alumunum chloride · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 alumunum chloride · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 alumunum chloride · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.36 mg/cm2 aluminum chloride · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.36 mg/cm2 aluminum chloride · Number Negative
|
104 Participants
|
|
Number of Participants With Patch Test Responses
0.36 mg/cm2 aluminum chloride · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.72 mg/cm2 aluminum chloride · Number Positive
|
4 Participants
|
|
Number of Participants With Patch Test Responses
0.72 mg/cm2 aluminum chloride · Number Negative
|
101 Participants
|
|
Number of Participants With Patch Test Responses
0.72 mg/cm2 aluminum chloride · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.047 mg/cm2 aluminum lactate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.047 mg/cm2 aluminum lactate · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.047 mg/cm2 aluminum lactate · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg/cm2 aluminum lactate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg/cm2 aluminum lactate · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg/cm2 aluminum lactate · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.42 mg/cm2 aluminum lactate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.42 mg/cm2 aluminum lactate · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.42 mg/cm2 aluminum lactate · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.84 mg/cm2 aluminum lactate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.84 mg/cm2 aluminum lactate · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.84 mg/cm2 aluminum lactate · Number not tested
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 copper sulfate · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 copper sulfate · Number Negative
|
109 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 copper sulfate · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 copper sulfate · Number Positive
|
9 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 copper sulfate · Number Negative
|
102 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 copper sulfate · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.80 mg/cm2 copper sulfate · Number Positive
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.80 mg/cm2 copper sulfate · Number Negative
|
101 Participants
|
|
Number of Participants With Patch Test Responses
0.80 mg/cm2 copper sulfate · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 copper sulfate · Number Positive
|
16 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 copper sulfate · Number Negative
|
95 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 copper sulfate · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 manganese chloride · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 manganese chloride · Number Negative
|
103 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 manganese chloride · Number not tested
|
17 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 manganese chloride · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 manganese chloride · Number Negative
|
103 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 manganese chloride · Number not tested
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 manganese chloride · Number Positive
|
4 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 manganese chloride · Number Negative
|
99 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 manganese chloride · Number not tested
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 manganese chloride · Number Positive
|
29 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 manganese chloride · Number Negative
|
74 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 manganese chloride · Number not tested
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.0067 mg/cm2 ammonium molybdate · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.0067 mg/cm2 ammonium molybdate · Number Negative
|
103 Participants
|
|
Number of Participants With Patch Test Responses
0.0067 mg/cm2 ammonium molybdate · Number not tested
|
17 Participants
|
|
Number of Participants With Patch Test Responses
0.02 mg/cm2 ammonium molybdate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.02 mg/cm2 ammonium molybdate · Number Negative
|
104 Participants
|
|
Number of Participants With Patch Test Responses
0.02 mg/cm2 ammonium molybdate · Number not tested
|
17 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 ammonium molybdate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 ammonium molybdate · Number Negative
|
103 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 ammonium molybdate · Number not tested
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 ammonium molybdate · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 ammonium molybdate · Number Negative
|
103 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg/cm2 ammonium molybdate · Number not tested
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.0018 mg.cm2 tin chloride · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.0018 mg.cm2 tin chloride · Number Negative
|
110 Participants
|
|
Number of Participants With Patch Test Responses
0.0018 mg.cm2 tin chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.037 mg/cm2 tin chloride · Number Positive
|
4 Participants
|
|
Number of Participants With Patch Test Responses
0.037 mg/cm2 tin chloride · Number Negative
|
107 Participants
|
|
Number of Participants With Patch Test Responses
0.037 mg/cm2 tin chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg/cm2 tin chloride · Number Positive
|
25 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg/cm2 tin chloride · Number Negative
|
86 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg/cm2 tin chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.33 mg/cm2 tin chloride · Number Positive
|
65 Participants
|
|
Number of Participants With Patch Test Responses
0.33 mg/cm2 tin chloride · Number Negative
|
45 Participants
|
|
Number of Participants With Patch Test Responses
0.33 mg/cm2 tin chloride · Number not tested
|
11 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 titanium citrate · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 titanium citrate · Number Negative
|
108 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 titanium citrate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 titanium citrate · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 titanium citrate · Number Negative
|
107 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 titanium citrate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 titanium citrate · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 titanium citrate · Number Negative
|
106 Participants
|
|
Number of Participants With Patch Test Responses
0.07 mg Ti/cm2 titanium lactate · Number Negative
|
107 Participants
|
|
Number of Participants With Patch Test Responses
0.07 mg Ti/cm2 titanium lactate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg Ti/cm2 titanium lactate · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg Ti/cm2 titanium lactate · Number Negative
|
107 Participants
|
|
Number of Participants With Patch Test Responses
0.14 mg Ti/cm2 titanium lactate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.28 mg Ti/cm2 titanium lactate · Number Positive
|
4 Participants
|
|
Number of Participants With Patch Test Responses
0.28 mg Ti/cm2 titanium lactate · Number Negative
|
105 Participants
|
|
Number of Participants With Patch Test Responses
0.28 mg Ti/cm2 titanium lactate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.060 mg Ti/cm2 potassium titanium oxide oxalate · Number Positive
|
1 Participants
|
|
Number of Participants With Patch Test Responses
0.060 mg Ti/cm2 potassium titanium oxide oxalate · Number Negative
|
108 Participants
|
|
Number of Participants With Patch Test Responses
0.060 mg Ti/cm2 potassium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg Ti/cm2 potassium titanium oxide oxalate · Number Positive
|
5 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg Ti/cm2 potassium titanium oxide oxalate · Number Negative
|
104 Participants
|
|
Number of Participants With Patch Test Responses
0.12 mg Ti/cm2 potassium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg Ti/cm2 potassium titanium oxide oxalate · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg Ti/cm2 potassium titanium oxide oxalate · Number Negative
|
107 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg Ti/cm2 potassium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 ammonium titanium oxide oxalate · Number Positive
|
13 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 ammonium titanium oxide oxalate · Number Negative
|
96 Participants
|
|
Number of Participants With Patch Test Responses
0.055 mg Ti/cm2 ammonium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 ammonium titanium oxide oxalate · Number Positive
|
21 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 ammonium titanium oxide oxalate · Number Negative
|
88 Participants
|
|
Number of Participants With Patch Test Responses
0.11 mg Ti/cm2 ammonium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 ammonium titanium oxide oxalate · Number Positive
|
18 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 ammonium titanium oxide oxalate · Number Negative
|
91 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 ammonium titanium oxide oxalate · Number not tested
|
12 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium chloride · Number Positive
|
0 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium chloride · Number Negative
|
106 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium chloride · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium chloride · Number Positive
|
4 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium chloride · Number Negative
|
102 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium chloride · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium chloride · Number Positive
|
25 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium chloride · Number Negative
|
81 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium chloride · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium chloride · Number Positive
|
46 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium chloride · Number Negative
|
60 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium chloride · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium sulfate · Number Positive
|
6 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium sulfate · Number Negative
|
100 Participants
|
|
Number of Participants With Patch Test Responses
0.0042 mg V/cm2 vanadium sulfate · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium sulfate · Number Positive
|
7 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium sulfate · Number Negative
|
99 Participants
|
|
Number of Participants With Patch Test Responses
0.0083 mg V/cm2 vanadium sulfate · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium sulfate · Number Positive
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium sulfate · Number Negative
|
96 Participants
|
|
Number of Participants With Patch Test Responses
0.025 mg V/cm2 vanadium sulfate · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium sulfate · Number Positive
|
30 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium sulfate · Number Negative
|
76 Participants
|
|
Number of Participants With Patch Test Responses
0.050 mg V/cm2 vanadium sulfate · Number not tested
|
15 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 zinc chloride · Number Positive
|
2 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 zinc chloride · Number Negative
|
109 Participants
|
|
Number of Participants With Patch Test Responses
0.013 mg/cm2 zinc chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 zinc chloride · Number Positive
|
7 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 zinc chloride · Number Negative
|
104 Participants
|
|
Number of Participants With Patch Test Responses
0.040 mg/cm2 zinc chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 zinc chloride · Number Positive
|
13 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 zinc chloride · Number Negative
|
98 Participants
|
|
Number of Participants With Patch Test Responses
0.080 mg/cm2 zinc chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 zinc chloride · Number Positive
|
69 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 zinc chloride · Number Negative
|
42 Participants
|
|
Number of Participants With Patch Test Responses
0.24 mg/cm2 zinc chloride · Number not tested
|
10 Participants
|
|
Number of Participants With Patch Test Responses
0.22 mg Ti/cm2 titanium citrate · Number not tested
|
13 Participants
|
|
Number of Participants With Patch Test Responses
0.07 mg Ti/cm2 titanium lactate · Number Positive
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 2, visit 2 prior to panel removalPanel Adhesion was measured at Visit 2 (day 2) prior to panel removal according to the following scale: Excellent- Skin contact good; all tape edges adherent; all allergens in contact with the skin, Good- Skin contact acceptable; some tape edges lifting; all allergens in contact with the skin, Poor- Little to no skin contact with panel; one or more allergens not in contact with the skin, Detached- Panel completely off the skin; none of the allergens in contact with the skin
Outcome measures
| Measure |
All Subjects
n=121 Participants
All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. Allergen response pattern included number of positive responses that were late (initially observed at day 7 or later) or persistent (positive response that persisted from one study visit to the next) and number of negative responses that were doubtful or irritant.
|
|---|---|
|
Number of Subjects With Panel Adhesion
Panel 1 Adhesion · Excellent
|
102 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 1 Adhesion · Good
|
1 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 1 Adhesion · Poor
|
2 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 1 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 1 Adhesion · Not Tested
|
16 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 2 Adhesion · Excellent
|
103 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 2 Adhesion · Good
|
3 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 2 Adhesion · Poor
|
5 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 2 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 2 Adhesion · Not Tested
|
10 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 3 Adhesion · Excellent
|
98 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 3 Adhesion · Good
|
3 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 3 Adhesion · Poor
|
3 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 3 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 3 Adhesion · Not Tested
|
17 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 4 Adhesion · Excellent
|
105 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 4 Adhesion · Good
|
1 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 4 Adhesion · Poor
|
3 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 4 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 4 Adhesion · Not Tested
|
12 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 5 Adhesion · Excellent
|
100 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 5 Adhesion · Poor
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 5 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 5 Adhesion · Not Tested
|
15 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 6 Adhesion · Excellent
|
113 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 6 Adhesion · Good
|
5 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 6 Adhesion · Poor
|
2 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 6 Adhesion · Detached
|
0 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 6 Adhesion · Not Tested
|
1 Participants
|
|
Number of Subjects With Panel Adhesion
Panel 5 Adhesion · Good
|
6 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6Tape irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated tape irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group.
Outcome measures
| Measure |
All Subjects
n=121 Participants
All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. Allergen response pattern included number of positive responses that were late (initially observed at day 7 or later) or persistent (positive response that persisted from one study visit to the next) and number of negative responses that were doubtful or irritant.
|
|---|---|
|
Tape Irritation
Panel 1 Tape Irritation · None
|
103 Participants
|
|
Tape Irritation
Panel 1 Tape Irritation · Irritant
|
2 Participants
|
|
Tape Irritation
Panel 1 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 1 Tape Irritation · Not Tested
|
16 Participants
|
|
Tape Irritation
Panel 2 Tape Irritation · None
|
109 Participants
|
|
Tape Irritation
Panel 2 Tape Irritation · Irritant
|
2 Participants
|
|
Tape Irritation
Panel 2 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 2 Tape Irritation · Not Tested
|
10 Participants
|
|
Tape Irritation
Panel 3 Tape Irritation · None
|
103 Participants
|
|
Tape Irritation
Panel 3 Tape Irritation · Irritant
|
1 Participants
|
|
Tape Irritation
Panel 3 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 3 Tape Irritation · Not Tested
|
17 Participants
|
|
Tape Irritation
Panel 4 Tape Irritation · None
|
108 Participants
|
|
Tape Irritation
Panel 4 Tape Irritation · Irritant
|
1 Participants
|
|
Tape Irritation
Panel 4 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 4 Tape Irritation · Not Tested
|
12 Participants
|
|
Tape Irritation
Panel 5 Tape Irritation · None
|
105 Participants
|
|
Tape Irritation
Panel 5 Tape Irritation · Irritant
|
1 Participants
|
|
Tape Irritation
Panel 5 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 5 Tape Irritation · Not Tested
|
15 Participants
|
|
Tape Irritation
Panel 6 Tape Irritation · None
|
119 Participants
|
|
Tape Irritation
Panel 6 Tape Irritation · Irritant
|
1 Participants
|
|
Tape Irritation
Panel 6 Tape Irritation · Allergic
|
0 Participants
|
|
Tape Irritation
Panel 6 Tape Irritation · Not Tested
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6Chip irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated Chip irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group.
Outcome measures
| Measure |
All Subjects
n=121 Participants
All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. Allergen response pattern included number of positive responses that were late (initially observed at day 7 or later) or persistent (positive response that persisted from one study visit to the next) and number of negative responses that were doubtful or irritant.
|
|---|---|
|
Chip Irritation
Panel 1 Chip Irritation · None
|
105 Participants
|
|
Chip Irritation
Panel 1 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 1 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 1 Chip Irritation · Not Tested
|
16 Participants
|
|
Chip Irritation
Panel 2 Chip Irritation · None
|
111 Participants
|
|
Chip Irritation
Panel 2 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 2 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 2 Chip Irritation · Not Tested
|
10 Participants
|
|
Chip Irritation
Panel 3 Chip Irritation · None
|
104 Participants
|
|
Chip Irritation
Panel 3 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 3 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 3 Chip Irritation · Not Tested
|
17 Participants
|
|
Chip Irritation
Panel 4 Chip Irritation · None
|
109 Participants
|
|
Chip Irritation
Panel 4 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 4 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 4 Chip Irritation · Not Tested
|
12 Participants
|
|
Chip Irritation
Panel 5 Chip Irritation · None
|
106 Participants
|
|
Chip Irritation
Panel 5 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 5 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 5 Chip Irritation · Not Tested
|
15 Participants
|
|
Chip Irritation
Panel 6 Chip Irritation · None
|
120 Participants
|
|
Chip Irritation
Panel 6 Chip Irritation · Irritant
|
0 Participants
|
|
Chip Irritation
Panel 6 Chip Irritation · Allergic
|
0 Participants
|
|
Chip Irritation
Panel 6 Chip Irritation · Not Tested
|
1 Participants
|
Adverse Events
All Subjects
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects
n=122 participants at risk
Subjects patched with at least 1 patch test panel were included in adverse event reporting.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal carcinoma of right breast
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
Other adverse events
| Measure |
All Subjects
n=122 participants at risk
Subjects patched with at least 1 patch test panel were included in adverse event reporting.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Eye disorders
Dry eye
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Eye disorders
Hordeolum
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Glossitis
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Periodontal inflammation
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Toothache
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Application site erythema
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Fatigue
|
2.5%
3/122 • Number of events 3 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Inflammation
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Influenza-like illness
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Malaise
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
General disorders
Pyrexia
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Infections and infestations
Cystitis
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
3/122 • Number of events 3 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Nervous system disorders
Dizziness
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Nervous system disorders
Headache
|
2.5%
3/122 • Number of events 3 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Nervous system disorders
Tension headache
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/122 • Number of events 2 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Surgical and medical procedures
Endodontic tooth pain
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
|
Surgical and medical procedures
Therapeutic nerve ablation
|
0.82%
1/122 • Number of events 1 • Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place