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The purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.
This is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of mercury, aluminum and palladium in 20 adult subjects who have a clinical history of contact dermatitis and have had a past positive patch test to one of the allergens on this study. Investigators and subjects will be blinded to the exact location of each dose within the allergen panel but will not be blinded to the allergen being tested, nor the range of allergen doses within each panel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ammoniated mercury | Experimental | 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. |
|
| Aluminum chloride and aluminum lactate | Experimental | 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. |
|
| Sodium tetrachloropalladaate (Palladium) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammoniated mercury | Diagnostic Test | Metal allergen panel containing ascending doses of ammoniated mercury and a negative control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application. | Tape 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. |
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Inclusion Criteria:
1.15 years of age or older.
2. History of contact dermatitis.
3. Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate) or 3) palladium (sodium tetrachloropalladate and/or palladium chloride) within the past 10 years.
4. Male or non-pregnant non-lactating female. Female subjects must state, at visit one that they are not pregnant, not lactating nor are they intending to become pregnant for the course of the study.
5. Has understood and signed the approved Informed Consent/Assent Form, which is consistent with all institutional, local and national regulations. Assent Form for all minor subjects (ages 15-17) must be signed by the guardian/parent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Isaksson, MD | Skane University Hospital Malmo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospital Malmo | Malmö | SE-205 02 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration | 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. | Not all subjects were tested with all allergens. Each panel had a different number of ascending doses. | Posted | Count of Participants | Participants | 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 |
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. It was impossible to know which allergen dose was associated with a related adverse event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock hypoglycemic | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment | Emergency services called for insulin shock. Subject administered sugar infusion and Novorapid. Event resolved same evening. Investigator considered event serious but as it did not meet the criteria for an SAE it was not reported as such. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment | Muscle pain, left side of torso |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Shannon | Allerdern (dba) SmartPractice | 602 225 0595 | 7208 | kshannon@smarthealth.com |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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Biologic
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| Aluminum chloride and aluminum lactate | Diagnostic Test | Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control. |
|
| Sodium tetrachloropalladate | Diagnostic Test | Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control. |
|
| Day 2: 48 hours after application |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| Secondary | Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application. | Tape 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. | Posted | Count of Participants | Participants | Day 2: 48 hours after application |
|
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|
| 0 |
| 21 |
| 1 |
| 21 |
| 6 |
| 21 |
| EG001 | 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. It was impossible to know which allergen dose was associated with a related adverse event | 0 | 13 | 0 | 13 | 3 | 13 |
| EG002 | 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. It was impossible to know which allergen dose was associated with a related adverse event | 0 | 22 | 0 | 22 | 9 | 22 |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Vesicles in nose |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Vesicles in mouth |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Vesicles on foot |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Vesicles on fingers |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Acne-like lesions on posterior aspect of trunk |
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| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment | Allergic reaction on upper posterior aspect of trunk |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Bilateral upper arm pruritus |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Eczema in both axillae |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Erythematous scaling on no. 3 fingers, both hands |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment | Fever |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment | Headache |
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| Herpes Zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment | Herpes Zoster |
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| Herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment | Herpes zoster on the back |
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| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Itching on the back patch test sites- left side |
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| Lichenification | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Oral lichenoid lesions, left side |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment | Pain in shoulder |
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| Application site papules | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Papules on upper posterior aspect of trunk |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Pruritus on back |
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| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Pruritus on the back at the test area |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Pruritus on left side of back |
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| Complex regional pain | Nervous system disorders | MedDRA 19.1 | Systematic Assessment | Upper back causalgia |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment | Pruritus on upper posterior aspect of trunk |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment | Upper respiratory tract infection |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Number Doubtful |
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| Number Irritant |
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| Number Negative |
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| Moderate |
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| Strong |
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| Itching |
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| Burning |
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