Trial Outcomes & Findings for Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study (NCT NCT02028208)
NCT ID: NCT02028208
Last Updated: 2020-08-24
Results Overview
Subjects were patch tested with 4 doses of mercury (0.00mg/cm2-neg control, 0.013 mg/cm2-dose 1, 0.040 mg/cm2-dose 2, 0.12 mg/cm2-dose 3 and 0.36 mg/cm2-dose 4) or 0 doses of aluminum (0.00 mg/cm2-neg control, 0.40 mg/cm2 aluminum chloride-dose 1, 0.12 mg/cm2 aluminum chloride-dose 2, 0.36 mg/cm2 aluminum chloride-dose 3 and 0.72 mg/cm2 aluminum chloride-dose 4, 0.047mg/cm2 aluminum lactate-dose 5, 0.14 mg/cm2 aluminum lactate-dose 6, 0.42 mg/cm2 aluminum lactate-dose 7, 0.84 mg/cm2 aluminum lactate-dose 8) or 5 doses of palladium (0.00 mg/cm2-neg control, 0.011 mg/cm2- dose 1, 0.033 mg/cm2- dose 2, 0.10 mg/cm2- dose 3, 0.30 mg/cm2- dose 4 and 0.60 mg/cm2- dose 5)..Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+, 2+ or 3+during at least one post removal visit. Overall results are based on Investigator determination following the final study visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Patch test sites were evaluated at days 3, 7, 10, 14, and 21 days after application. Results are based on Investigator's review of reactions following the day 21 evaluation
Results posted on
2020-08-24
Participant Flow
Participant milestones
| Measure |
Ammoniated Mercury
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
|
Aluminum Chloride and Aluminum Lactate
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
|
Sodium Tetrachloropalladaate (Palladium)
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
13
|
22
|
|
Overall Study
COMPLETED
|
21
|
13
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Baseline characteristics by cohort
| Measure |
Ammoniated Mercury
n=21 Participants
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
|
Aluminum Chloride and Aluminum Lactate
n=13 Participants
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
|
Sodium Tetrachloropalladaate (Palladium)
n=22 Participants
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indigenous swede
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Sami
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Finn
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Patch test sites were evaluated at days 3, 7, 10, 14, and 21 days after application. Results are based on Investigator's review of reactions following the day 21 evaluationPopulation: Not all subjects were tested with all allergens. Each panel had a different number of ascending doses.
Subjects were patch tested with 4 doses of mercury (0.00mg/cm2-neg control, 0.013 mg/cm2-dose 1, 0.040 mg/cm2-dose 2, 0.12 mg/cm2-dose 3 and 0.36 mg/cm2-dose 4) or 0 doses of aluminum (0.00 mg/cm2-neg control, 0.40 mg/cm2 aluminum chloride-dose 1, 0.12 mg/cm2 aluminum chloride-dose 2, 0.36 mg/cm2 aluminum chloride-dose 3 and 0.72 mg/cm2 aluminum chloride-dose 4, 0.047mg/cm2 aluminum lactate-dose 5, 0.14 mg/cm2 aluminum lactate-dose 6, 0.42 mg/cm2 aluminum lactate-dose 7, 0.84 mg/cm2 aluminum lactate-dose 8) or 5 doses of palladium (0.00 mg/cm2-neg control, 0.011 mg/cm2- dose 1, 0.033 mg/cm2- dose 2, 0.10 mg/cm2- dose 3, 0.30 mg/cm2- dose 4 and 0.60 mg/cm2- dose 5)..Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+, 2+ or 3+during at least one post removal visit. Overall results are based on Investigator determination following the final study visit.
Outcome measures
| Measure |
Ammoniated Mercury
n=21 Participants
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
|
Aluminum Chloride and Aluminum Lactate
n=13 Participants
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
|
Sodium Tetrachloropalladaate (Palladium)
n=21 Participants
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
|
|---|---|---|---|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 1 · Number Irritant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 2 · Number Irritant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 3 · Number Negative
|
5 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Negative Control · Number Positive
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Negative Control · Number Irritant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Negative Control · Number Negative
|
15 Participants
|
11 Participants
|
21 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 1 · Number Positive
|
10 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 1 · Number Doubtful
|
5 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 1 · Number Negative
|
6 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 2 · Number Positive
|
16 Participants
|
0 Participants
|
13 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 2 · Number Doubtful
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 2 · Number Negative
|
2 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 3 · Number Positive
|
14 Participants
|
1 Participants
|
15 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 3 · Number Doubtful
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 3 · Number Irritant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 4 · Number Positive
|
15 Participants
|
2 Participants
|
18 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 4 · Number Doubtful
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 4 · Number Irritant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 4 · Number Negative
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 5 · Number Positive
|
—
|
0 Participants
|
20 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 5 · Number Doubtful
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 5 · Number Irritant
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 5 · Number Negative
|
—
|
13 Participants
|
1 Participants
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 6 · Number Positive
|
—
|
0 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 6 · Number Doubtful
|
—
|
1 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 6 · Number Irritant
|
—
|
0 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 6 · Number Negative
|
—
|
12 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 7 · Number Positive
|
—
|
0 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 7 · Number Doubtful
|
—
|
3 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 7 · Number Irritant
|
—
|
0 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 7 · Number Negative
|
—
|
10 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 8 · Number Positive
|
—
|
1 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 8 · Number Doubtful
|
—
|
5 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 8 · Number Irritant
|
—
|
0 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Dose 8 · Number Negative
|
—
|
7 Participants
|
—
|
|
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Negative Control · Number Doubtful
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2: 48 hours after applicationTape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions. Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses.
Outcome measures
| Measure |
Ammoniated Mercury
n=21 Participants
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Ammoniated mercury: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
|
Aluminum Chloride and Aluminum Lactate
n=13 Participants
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Aluminum chloride and aluminum lactate: Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
|
Sodium Tetrachloropalladaate (Palladium)
n=21 Participants
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Sodium tetrachloropalladate: Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
|
|---|---|---|---|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Burning · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Burning · Strong
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Tape Irritation · None
|
17 Participants
|
9 Participants
|
21 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Tape Irritation · Weak
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Tape Irritation · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Tape Irritation · Strong
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Itching · None
|
12 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Itching · Weak
|
8 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Itching · Moderate
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Itching · Strong
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Burning · None
|
20 Participants
|
9 Participants
|
19 Participants
|
|
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Burning · Weak
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Ammoniated Mercury
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Aluminum Chloride and Aluminum Lactate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sodium Tetrachloropalladaate (Palladium)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ammoniated Mercury
n=21 participants at risk
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
Aluminum Chloride and Aluminum Lactate
n=13 participants at risk
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
Sodium Tetrachloropalladaate (Palladium)
n=22 participants at risk
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Shock hypoglycemic
|
4.8%
1/21 • Number of events 1 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
Other adverse events
| Measure |
Ammoniated Mercury
n=21 participants at risk
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
Aluminum Chloride and Aluminum Lactate
n=13 participants at risk
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
Sodium Tetrachloropalladaate (Palladium)
n=22 participants at risk
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
It was impossible to know which allergen dose was associated with a related adverse event
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
7.7%
1/13 • Number of events 5 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
7.7%
1/13 • Number of events 5 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
7.7%
1/13 • Number of events 5 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Infections and infestations
Herpes
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
4.5%
1/22 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Skin and subcutaneous tissue disorders
Application site papules
|
0.00%
0/21 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
7.7%
1/13 • Number of events 5 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Nervous system disorders
Complex regional pain
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
1/21 • Number of events 11 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/13 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
0.00%
0/22 • Adverse events were reported beginning at the 2nd visit (day 2) through the end of the study, (day 19-23)
Subjects were asked at each visit if they had any changes to their general health or use of concomitant medications
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place